Accepted Manuscript

Is the routine practice of antibiotic prescription and microbial culture & antibiotic
sensitivity testing justified in primary maxillofacial space infection patients? - a
prospective, randomized, comparative clinical study

Saroj Kumari, MDS, Oral and Maxillofacial Surgery, Senior Resident, Sujata Mohanty,
MDS, Oral and Maxillofacial Surgery, Professor and Head, Pankaj Sharma, MDS,
Oral and Maxillofacial Surgery, Associate Professor, Jitender Dabas, MDS, Oral and
Maxillofacial Surgery, Senior Resident, Sanchaita Kohli, MDS, Oral and Maxillofacial
Surgery, Senior Resident, Cathrine Diana, MDS, Oral and Maxillofacial Surgery,
Academic Resident
PII: S1010-5182(17)30419-5
DOI: 10.1016/j.jcms.2017.11.026
Reference: YJCMS 2851

To appear in: Journal of Cranio-Maxillo-Facial Surgery

Received Date: 18 May 2017

Revised Date: 12 September 2017
Accepted Date: 30 November 2017

Please cite this article as: Kumari S, Mohanty S, Sharma P, Dabas J, Kohli S, Diana C, Is the routine
practice of antibiotic prescription and microbial culture & antibiotic sensitivity testing justified in primary
maxillofacial space infection patients? - a prospective, randomized, comparative clinical study, Journal of
Cranio-Maxillofacial Surgery (2018), doi: 10.1016/j.jcms.2017.11.026.

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 ACCEPTED MANUSCRIPT

Title: Is the routine practice of antibiotic prescription and microbial culture & antibiotic
sensitivity testing justified in primary maxillofacial space infection patients? - a prospective,
randomized, comparative clinical study

Authors:
Saroj Kumari, MDS, Oral and Maxillofacial Surgerya
Sujata Mohanty, MDS, Oral and Maxillofacial Surgeryb

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Pankaj Sharma, MDS, Oral and Maxillofacial Surgeryc
Jitender Dabas, MDS, Oral and Maxillofacial Surgeryd
Sanchaita Kohli, MDS, Oral and Maxillofacial Surgerye

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Cathrine Diana, MDS, Oral and Maxillofacial Surgeryf

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a. Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
ID: dr.sarojsheoran@gmail.com

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b. Professor and Head, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
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ID: drsm28@gmail.com.
c. Associate Professor, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
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ID: spankaj_in@yahoo.com.
d. Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
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Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
ID: jits.osmaids@gmail.com.
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e. Senior Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
ID: sanchaita.kohli@gmail.com.
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f. Academic Resident, Department of Oral and Maxillofacial Surgery, Maulana Azad Institute of
Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi – 110002, India; Email
ID: cathyben263@gmail.com
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Corresponding Author:
Dr Saroj Kumari,
Senior Resident, Department of Oral and Maxillofacial Surgery (1st floor), Maulana Azad
Institute of Dental Sciences, MAMC Complex, Bahadur Shah Zafar Marg, New Delhi-
110002
Email id: dr.sarojsheoran@gmail.com
Phone no: 9999404067
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Summary

Purpose: The purpose of this prospective, randomized, comparative clinical study was to compare

treatment outcome of removal of foci and incision and drainage, with or without oral antibiotic

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therapy, in the management of single primary maxillofacial space infection with a known focus.

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Materials and Methods: A total of 40 patients with single primary maxillofacial space infection

with a known infectious focus were divided into two groups, one treated with incision and

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drainage only, and the other with incision and drainage along with oral antibiotics. The focus of

infection was addressed in both groups. Parameters evaluated included pain score, maximum

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mouth opening, swelling, purulent discharge and return to normal life, which were assessed on
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days 1, 2, 3, 5 and 7. The patients were followed up until they reported return to normal life as

assessed by a questionnaire.
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Results: All of the patients rapidly responded to treatment as observed by a reduction in pain,
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swelling, discharge, and improvement in mouth opening. Pus discharge stopped within first 3 days
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in 75% of patients. The patients who underwent immediate extraction showed a faster resolution

of infection (mean return to normal life = 9 days) than others (mean = 11.2 days). There was no
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statistically significant difference between the two groups for the five study parameters (p<0.05).

Of the total pus specimens, 75% had no significant bacterial growth, or grew ‘oral flora’/
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contaminants, while only 25% grew specific bacteria.

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Conclusion: This study questions the conventional practice by dental practitioners and surgeons

of prescribing antibiotics to all patients with odontogenic infection. Microbial culture and

antibiotic sensitivity is of little therapeutic value in selected patient groups.

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Keywords: maxillofacial space infections, incision and drainage, microbial culture and antibiotic

sensitivity testing

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INTRODUCTION

Maxillofacial space infections (MSIs) are one of the most frequently occurring infectious

processes known to both antiquity and present-day health practice, and appear to have troubled the

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human race for as long as our species has existed (Hought et al., 1980; Sandor et al., 1988; Polk,

1999; Chunduri et al., 2012; Mathew et al., 2012). It is generally believed that the advent of

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antibiotics has led to a substantial reduction in the incidence of MSI. Despite this popular belief,

Dr. Walter Guralnick, in his studies, accredited a dramatic reduction in mortality (from 54% to

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10%) to the principles of establishment of a secure airway, followed by immediate and aggressive

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surgical drainage of all involved anatomic spaces, rather than antibiotics (Williams and Guralnick,
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1943).

MSIs are usually odontogenic in origin, most frequently being of a polymicrobial nature.
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Promoting the use of empirical antibiotics to cover the broad spectrum of microorganisms often
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leads to a wide range of side effects along with the possible emergence of bacterial resistance

(Bahl et al., 2014). Microbial culture and antibiotic sensitivity testing (CST) is considered
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mandatory if a targeted antibiotic regimen is to be prescribed to prevent the aforementioned

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consequences. However, it markedly increases the cost and results in a considerable delay in the

commencement of targeted treatment (Farmahan et al., 2014; Farzadi et al., 2015).

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The most important therapeutic modality for pyogenic orofacial infections is surgical drainage and
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definitive restoration or extraction of the infected tooth, which is the primary source of infection

and removal of any other source of infection such as sequestrum, foreign body, etc. (Peterson,

2002).
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No pertinent literature to date is available to highlight the importance of surgery (inclusive of

incision and drainage [I & D] and removal of foci) as an exclusive modality over a combination of

surgery and antibiotics for management of MSIs. The aim of the current study was to assess the

tangible merit of antimicrobial therapy by comparing treatment outcome achieved following

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surgical I & D with or without antibiotics, provided that the focus of infection was always taken

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care of. The clinical significance of CST in MSI patients was also evaluated.

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MATERIALS AND METHODS

Study design
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This prospective, randomized clinical study was carried out in the Department of Oral and
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Maxillofacial Surgery at the author’s institution over a period of 19 months (September 2014 to

March 2016). Considering the 25% of minimum effective difference (α=5%, β=10%,
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power=90%), a sample size of 39 was calculated, which was rounded off to 40 for the study.
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Figure 1 summarizes the recruitment process of the study. Patients were included in the study

considering the inclusion and exclusion criteria shown in Figure 2. Prior approval of the
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institutional review board, permission from the local ethical committee, and written informed

consent from the patients or patients’ parents were obtained for the study. Pre-operative work-up
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included a detailed history, thorough clinical examination, routine blood investigations for
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assessment of immunological status, and radiographic evaluation for identification of the focus

of infection. The patients were randomized by the block method (using blocks of four) into two

groups as summarized in Table 1. The randomization technique was by drawing lots. All of the
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data were collected, recorded, and analyzed by the same observer, who was blinded to the study

group to reduce observation bias.

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Procedure

All patients were given the same surgical care under aseptic condition by a single surgeon.

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Immediate treatment was given in the form of I & D of the involved space under local anesthesia.

The incision was placed on the most dependent, esthetically acceptable, and healthy skin or

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mucosa whenever possible, followed by blunt dissection with Halstead mosquito artery forceps to

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disrupt the compartmentalized infected areas. A sterile corrugated rubber drain was placed in all
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cases and fixed using a suture to secure the drainage patency. The pus or exudate obtained at the

first visit was collected and sent for microbial culture and antibiotic sensitivity testing. The
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offending tooth was managed by dental extraction or endodontic treatment as soon as a favorable

mouth opening was achieved following surgical drainage.

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Postoperative assessment
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The site of infection was cleaned and thoroughly irrigated with hydrogen peroxide, povidone

iodine, and normal saline on each follow up visit. The rubber drain was changed every 48 hours
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until discharge was present. Patients were evaluated on days 1, 2, 3, 5, and 7 for resolution of
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infection, using the parameters listed in Table 2. The patients were followed up until they reported

return to normal life as assessed by a questionnaire (Table 2). Among 49 patients included in the

study, 9 failed to comply with the follow-up protocol and were excluded from the study. None of
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these 9 patients returned for follow-up after the day 3 visit, but signs of resolution of the infection

were noted until their last follow-up.

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Data analysis

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Finally, the data obtained were statistically analyzed for 40 patients only, using SPSS version 20,

as rest of the patients did not return for follow-up. The data collected were analyzed by the

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Pearson chi-square test for qualitative variables and Student t-test for quantitative variables. A 5%

probability level was considered as statistically significant (p<0.05).

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RESULTS
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A total of 40 patients in the age range of 10 to 50 years (mean = 27.3 years) with a single primary
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odontogenic MSI were divided into 2 groups (n = 20 each), i.e. with antibiotics (Group A) and
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without antibiotics (Group B). An overall male-to-female ratio of 3:2 was observed. Mandibular

molar teeth were found to be most frequently involved (70%, n=28) comprising 32.5%, 22.5%
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and 15% of mandibular third, first, and second molars, respectively. The fascial space most

commonly involved was the buccal space (42%), followed by submasseteric space (37%) and
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submandibular space (10%) (Figure 3). Removal of foci (either by extraction or endodontic
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procedure) was done on day 1 in 25 patients, and delayed in 15 patients (n=10 group A, n=5 group

B) due to restricted mouth opening. Surgical drainage was accomplished via an extraoral approach

in 16 patients and intraorally in 24 patients (Table 3).

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Pain

The main outcome was pain, evaluated using a numerical rating scale with highest mean value

noted on day 1 (mean score = 8.6 for group A and 8.5 for group B, p = 0.842) and minimum on

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day 7 with mean score of 0.75 for group A and 1.00 for group B (p = 0.420). The majority of the

patients became pain-free by day 7, with a mean pain score <1 (n =18 [90%], group A; n=13

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[65%], group B). The difference in the mean pain scores between group A and B was not found to

be clinically significant at any follow up visit (p>0.05) (Figure 4).

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Mouth opening
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A gradual increase in mean mouth opening was seen in both groups at each visit. Mean mouth
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opening was 25.8 mm and 29.5 mm for group A and B respectively on day 1, whereas it was

32.25 mm and 35.7 mm on day 7 for group A and B respectively . The percentage increase in
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mouth opening was 25% and 21% for group A and B respectively between day 1 and day 7. A
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total of 14 patients (70%) in each group achieved a mouth opening measuring 30 mm or more on

day 7. There was no statistically significant difference in increase in mouth opening between the
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two study groups at any follow-up visit (p>0.05) (Figure 4).

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Swelling

The mean value of swelling on day 1 was 4566.40 square millimeters for group A and 4070.40 for

group B. The mean value was maximal on day 2 for both groups (group A, mean = 4581.65; group

B, mean= 4347.40). On day 7, the mean value was minimum for both the groups (group A, mean
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= 1729.20; group B, mean = 1419.25). There was no statistically significant difference in the

increase or decrease in swelling between the two study groups at any follow-up visit (p>0.05)

(Figure 4).

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Purulent discharge

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Purulent discharge stopped within first 3 days in 75% of the patients (37.5% in each group). None

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of the patients showed purulent discharge after 1 week of follow-up. Gradual reduction of

discharge was noted on subsequent postoperative visits in both groups. There was no statistically

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significant difference in resolution of discharge between the two groups (p>0.05) (Table 3).
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Return to normal life

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Overall, 47.5% of patients (n=19) reported “return to a normal life” on day 7 including 20%
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patients in group A and 27.5% in group B. A total of 20% (n=8) reported return to normal life till

day 10 (group A: 12.5% and group B: 7.5%), 27.5% (n=11) till day 15 (group A: 15% and group
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B: 12.5%), and 5% (n=2) till day 17 (group A: 2.5% and group B: 2.5%). There was no

statistically significant difference in return to normal life between the 2 groups (p>0.05) (Table 3).
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CST

The pus/exudate obtained at the first visit was collected and sent for microbial culture and

antibiotic sensitivity testing. In all, 67.5% of the specimens (n=27) had no significant bacterial

growth, and 7.5% (n=3) grew “oral flora”/ contaminants. Of the total specimens, 25% (n=10) grew
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specific bacteria, including Eschirichia coli (3), Streptococci sp, (2) Staphylococci sp (2), Proteus

(1), Pseudomonas (1), and Actinobactor sp (1) (Table 3).

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DISCUSSION

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The incidence, severity, morbidity, and mortality associated with orofacial infections has dropped

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dramatically over the past 76 years. In 1940, Ashbel Williams published a series of 31 cases of

Ludwig’s angina with 54% mortality (Willium, 1940). Only 3 years later, he and Dr. Walter

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Guralnick published a prospective case series of MSIs, in which the mortality rate of Ludwig’s
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angina was reduced to 10%. This dramatic reduction in mortality was not due to the use of
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penicillin in the treatment of such infections; rather, Dr. Guralnick attributed this to primarily

securing the airway, followed by early and aggressive surgical drainage of all involved anatomic
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spaces (Williams and Guralnick, 1943). Later, in 1979, Hought et al. reported reduction of
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mortality to 4% in a review on Ludwig’s angina (Hought et al., 1980). This reduction in mortality

over that period of time was perhaps because of progress in prevention and early treatment to
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odontogenic infections (Flynn, 2002).

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Many surgeons believe that tooth extraction in the presence of an acute infection may cause the
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bacteria to seed into the fascial spaces. However, Gluck, Wainwright, and later Igoumenakis

reported that early extraction of the offending tooth is associated with a faster clinical and

biochemical resolution of the infection without any postoperative life-threatening infections

(Gluck, 1939; Wainwright, 1940; Igoumenakis, 2015).

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Facial space infections mandate appropriate and timely treatment, owing to their ability to spread

along maxillofacial spaces, resulting in life-threatening complications. Treatment options for MSIs

include instituting antibiotics, immediate I & D, or a combination thereof; however, a debate

regarding the most suitable modality of treatment still persists. Traditional algorithms were based

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on the presence or absence of an abscess. If a localized, fluctuant swelling (suggestive of an

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abscess) could be appreciated on palpation, the patients underwent surgical drainage. Similarly, if

a diffuse, indurated swelling (suggestive of cellulitis) was appreciated on palpation, the patient

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received only antibiotics (Courtney et al., 2007). This approach was based more on opinion than

on supporting facts.

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Many authors recommend early surgical drainage for all facial space infections:
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1. “When a case fulfils the criteria prerequisite to a diagnosis of Ludwig’s angina, immediate

surgical drainage is indicated. While one waits, he is exposing his patient to the grave
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complications.” (Williams, 1940)

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2. “To carry out the premise of early treatment, I & D of extraoral abscesses must be performed
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before the amount of tissue destruction and suppuration is sufficient to be detected by palpation.”

(Laskin, 1964)
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Most of the oral bacteria organize themselves in complex, nutrient-sufficient and symbiotic matrix

system known as biofilm. Antibiotics may improve the patient’s symptoms by killing the
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planktonic bacteria, but they fail to penetrate the biofilm, necessitating breakage of biofilm by
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mechanical and surgical means (Ray and Triplett, 2011).

In view of the earlier published literature, early surgical intervention by drainage of abscess was

done in the present study, along with removal of foci as soon as possible. It was based on the

hypothesis that removal of foci, along with I & D, is sufficient for management of single primary
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space infections in immunocompetent patients. Since unrestrained enthusiastic use of BSAs is

increasingly leading to emergence of resistant microbes without actually helping in the resolution

of MSIs, their use should be optimized and reserved for complicated situations.

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Strict inclusion criteria limited our final sample size to 40 patients out of 126 space infection

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patients. Our study had subjects ranging in age between 10 and 50 years. We excluded elderly

patients, as they are more prone to severe multi-space infections owing to systemic diseases (most

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commonly diabetes mellitus), reduced immunity, and insufficient oral hygiene (Zheng et al.,

2013). Children below 10 years were also excluded, considering risk of rapid systemic

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involvement (Sandor and Low, 1998), as full immunologic maturity is not reached until
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adolescence, and adaptive immunity is also suppressed (Ygberg et al., 2012).

A high male-to-female ratio (3:2) observed in our study corresponds with most of the previous
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studies (male:female ~ 2:1), and can be attributed to the fact that women tend to have better oral
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health and to seek oral health care more frequently (Mathew et al., 2012).
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Our study supports previous studies regarding the anatomical consideration of the etiology that

causes MSIs. For instance, in accordance with the studies by Haug et al. and Indresano et al.,
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molar teeth were the most common foci of infection (82.5%) in the present study (Haug et al.,
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1991; Indresano et al., 1992). The most common teeth responsible in our study were lower third
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molars (32.5%, 13/40), which is comparable to the findings of Mathew et al., who reported an

incidence of 36% in their study (Mathew et al., 2012). None of our study patients had a complete

impaction or position C of the mandibular third molar, indicating that the rate of infection is lower

with fully impacted teeth compared to partially impacted teeth, similar to findings of Ohshima et

al. (Oshima et al., 2004).

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In a study, Labriola et al. reviewed 50 cases of single- and multiple-space infections. They found

that the most frequently encountered infection was in the submandibular space (26%), followed by

buccal (21%), masticator (15%), and canine (13%) spaces (Labriola et al., 1983). In contrast to

the above-mentioned study, our findings showed the buccal space (42%) to be more commonly

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involved, followed by submassetric space (37%) and submandibular space (10%) involvements.

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This variation can be explained by the facts that we did not include multi-space infections and that

the submandibular space was more frequently involved in multiple-space infections, as noted by

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Haug et al., who found submandibular space involvement in 62% of multiple-space infection

patients (Haug et al., 1991).

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Removal of foci involved immediate/delayed extraction (due to restricted mouth opening) or root

canal treatment (if the tooth was salvageable). The patients who underwent immediate extraction
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showed faster resolution of infection (mean return to normal life = 9 days) than others (mean =

11.2 days). Our finding was supported by findings of Igoumenakis, who concluded that in
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odontogenic MSIs, extraction of the causative tooth is associated with a faster clinical and
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biological resolution of the infection (Igoumenakis, 2015). Reviews conducted by Johri and

Piecuch and by Flynn also corroborated these findings (Johri and Piecuch, 2011; Flynn, 2011).
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The main outcome was evaluated using a numerical rating scale, with highest mean noted on day
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1. Rapid reduction in pain was noted on day 2, followed by gradual reduction on subsequent
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postoperative visits. Pain was minimal on day 7, with mean of 0.75 for group A and 1.00 for group

B. Maximum mouth opening (MO) varied according to the space involved. In patients with

submassetric space involvement, the mouth opening was less compared to that of the other spaces

involved. Significant reduction in mouth opening in patients with involved submassetric spaces

can be explained by trismus resulting from spasm of the masseter muscle, whereas mild reduction
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in mouth opening in patients with other facial space involvement can be attributed to the patient’s

apprehension related to the underlying pain and swelling. In all of the patients, a gradual increase

in mouth opening was seen on subsequent postoperative visits. In our study, a lesser mean mouth

opening was observed in group A than in group B from day 1 to day 7. This can be attributed to

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the fact that group A had more patients with submassetric space involvement (40%) than group B

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(35%); thus the lower mean mouth opening. An increase in swelling was noted on day 2 followed

by substantial reduction in swelling on subsequent follow-up visits. Increase in swelling on day 2

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can be attributed to postsurgical edema. On day 7, the mean value of swelling was minimal for

both groups. This finding is in concurrence with findings by Bahl et al., who reported that

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swelling was present in all patients at the time of reporting, which was almost negligible on the
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seventh day of surgical management (Bahl et al., 2014). Opitz et al. reported that most patients

with severe odontogenic infections presents with clinical signs such as pain, swelling, trismus, or
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difficulty swallowing or breathing (Opitz et al., 2015). Most patients recover completely after
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adequate surgical treatment, antibiotic administration, and odontogenic focus removal (Poeschl et
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al., 2010; Bakir et al., 2012).

A greater number of patients with purulent discharge were noticed on days 1, 2, and 3. Gradual
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reduction of discharge was noted on subsequent postoperative visits. This finding is in

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concurrence with Adekeye and Adekeye, who reported that after the I & D, purulent exudates
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stopped within 2-3 days and resolution was complete within 5-12 days (Adekeye and Adekeye,

1982).

Return to normal life was assessed among all patients in the two groups by answering a

questionnaire regarding difficulty in speaking, difficulty in chewing, diet consistency, difficulty in

maintaining oral hygiene, sleeping, leaving home, and returning to work. A total of 47.5% of
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patients reported return to normal life on day 7, 47.5% on day 15, and 5% on day 17. This study is

in confluence with one conducted by Boscolo-Rizzo, who observed faster resolution of the space

infection and its symptoms in the study group treated with I & D and intravenous antibiotics than

in those patients managed with only intravenous antibiotics (Boscolo-Rizzo, 2012).

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Vig et al. conducted a retrospective analysis including 200 patients whose pus swabs were sent for

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CST following drainage, and found that the majority (145, 72.5%) had no significant bacterial

growth, or grew oral flora. Of the total swabs 24% (n = 48) grew specific bacteria (Staphylococci

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sp. 9% of total, Streptococci sp. 8%, anaerobes 5%, with Candida growth in 3.5% of the total) (Vig

et al., 2012). Mathew et al. also reported that 102 (83.6%) of 122 specimen did not have any

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bacterial growth on culture (Mathew et al., 2012). These findings are consistent with our results in
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which 75% (n=30) patients had no significant bacterial growth, or grew oral flora/contaminants.

In all, 25% (n=10) of total specimens grew specific bacteria. In spite of obtaining specific
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bacterial growth in only 25% of the cases, all patients responded well to treatment, leading us to
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question the routine use of empirical antibiotic therapy, CST, and subsequent use of specific
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antibiotic therapy.

In our study, there was no significant difference in resolution of pain, swelling, mouth opening,
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discharge and return to normal life between the two groups (group A: patients treated with
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removal of etiology and I & D along with oral antibiotic therapy; group B: patients treated with
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removal of etiology and I & D). Therefore, in view of the incidence of developing resistance

because of the overzealous use of antibiotics, we suggest early I & D along with removal of

etiology as the primary treatment modality for facial space infections, and suggest preferably

reserving antibiotics as a strategy for complicated cases (e.g. multiple, secondary, or deep neck

space infections in immunocompromised patients, etc.)

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The drawbacks associated with the study include a relatively small sample size; validity only for

patients with single primary orofacial space infection who fit the strict inclusion criteria; and the

subjective nature of parameters such as swelling and return to normal life. Additionally, the

patients in group A were on oral antibiotics, so the chances of patients missing a dose were also

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there.

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CONCLUSION

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Growing resistance to antibiotics in today’s world underlines a need to curb overuse of broad-

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spectrum antibiotics, which can be accomplished by assessing patients in need of cogent antibiotic
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therapy. Hence, concrete guidelines for management of maxillofacial space infection aimed at

early recognition, proper medical and surgical management, and simultaneously evaluating a
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patient’s medical status, constant vigilance, and understanding of possible catastrophic sequelae
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are the needs of the hour.

Surgical treatment comprises incision and drainage of involved space and concurrently treating the
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focus of infection (by extraction, endodontic therapy of infected teeth, removal of sequestrum or
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foreign body), which is of primary importance in the management of these patients. Additionally,

antibiotics may be administered in accordance with the patient’s medical status and drug
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affordability. Microbial culture is of little therapeutic value in the management of single

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maxillofacial space infection, with significant cost incurrence to patients.

This study questions the role of antibiotics in well-localized maxillofacial space infection with

known foci, especially in immunocompetent patients. However, multicentric, prospective,

randomized studies with a larger and more varied sample size should be undertaken to further

corroborate our findings.

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Acknowledgements

The authors express special thanks to Dr. Shivam Kapoor and Dr. Vaibhav Gupta for their

guidance in writing this article.

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Conflicts of interest

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The authors declare that there are no conflicts of interest in regard to this work.

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Funding

This research did not receive any specific grant from funding agencies in the public,

commercial, or not-for-profit sectors.

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Figure 1. CONSORT statement flow chart with regard to patient enrolment in the study.

Figure 2. Inclusion and exclusion criteria of the study.

Figure 3. Pie chart showing the distribution of involved spaces.

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Figure 4. Box whisker plots comparing outcome variables, i.e., pain (a), mouth opening (b), and

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swelling (c) in both study groups from day 1 to day 7.

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Table 1. Summary of treatment protocols in group A and B

GROUP METHOD MEDICATION

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A PATIENT TREATED WITH Aceclofenac-serratiopeptidase (100 mg +
• INCISION & DRAINAGE 15 mg) BID
• REMOVAL OF CAUSE EMPIRICAL Amoxicillin-clavulanic

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(extraction/RCT) ANTIBIOTIC acid
• ORAL ANTIBIOTIC THERAPY 625 mg TID
THERAPY

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Metronidazole
400 mg TID

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Ranitidine 150 mg SOS

B PATIENT TREATED WITH Aceclofenac-serratiopeptidase (100 mg +

• 15mg) BID
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INCISION & DRAINAGE

• REMOVAL OF Ranitidine 150 mg SOS
CAUSE (extraction/ RCT)
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Abbreviations used: RCT = root canal treatment; BID = twice daily, TID = three times daily; and SOS = as
needed.
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Table 2. Overview of study parameters

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S. No. Parameter Measurement
1 Pain score Assessed by Numerical Rating Pain score,
2 Maximum mouth Was measured (in mms) from incisal edge of maxillary
opening central incisor to incisal edge of mandibular central incisor

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of the affected side
3 Swelling Horizontal and vertical extension of swelling were marked
and measured after palpating the swelling with a flexible

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scale
4 Purulent discharge Presence, absence and type (purulent/ serosanguinous/
serous) of discharge was noted intraoperatively and on

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subsequent follow ups
5 Return to normal life Based on patient perception of recovery and was
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determined by asking questions on all follow up visits
referring to eating, speaking, and interference with daily
activities
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QUESTIONNAIRE
1. Are you experiencing any pain?
2. Are you having any difficulty in speaking?
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3. Are you having any difficulty in chewing?

4. Are you having any difficulty in maintaining oral
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hygiene activities?
5. Are you having any difficulty in performing other
daily activities (e.g. sleeping, going out of house, and
returning to work, etc.)?
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The day of negative answers to all the questions was

considered as day of return to normal life
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Table 3. Outline of cases
Cas Grou Ag Se Spac Drainage Foci Foci Discharge Return to CST
e p e x e remova present normal

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no. l until life
1 A 12 M Md Extra- 36 Day 1 1 15 No
oral

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2 A 17 M B Intra-oral 36 Day 1 2 9 No
3 A 18 F C Intra-oral 21 Day 1 2 7 No
4 A 28 M B Intra-oral 26 Day 1 2 7 No
5 A 26 F C Intra-oral 63 Day 1 3 10 Proteus

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6 A 21 M Ms Extra- 48 Day 3 3 10 No
oral
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7 A 24 M Ms Intra-oral 3 Day 3 3 10 No
8 A 22 F B Intra-oral 35 Day 1 3 7 No
9 A 10 F B Intra-oral 46,85 Day 1 2 7 No
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10 A 23 F Ms Extra- 47 Day 3 5 12 No
oral
11 A 14 M Md Extra- 37 Day 1 2 7 No
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oral
12 A 46 F Ms Extra- 37,38 Day 1 5 15 No
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oral
13 A 50 M B Intra-oral 26,27 Day 1 3 7 Staphyloccus
albus
14 A 20 M Md Intra-oral 38 Day 1 2 7 Eschirichia
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coli
15 A 12 M Md Extra- 46 Day 1 3 7 Eschirichia
oral coli
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16 A 50 M B Intra-oral 22,23 Day 1 2 10 Contaminants

17 A 50 M Ms Extra- 48 Day 8 7 12 Eschirichia
AC

oral coli
18 A 21 F Ms Intra-oral 38 Day 7 7 16 No
19 A 24 M Ms Extra- 38 Day 1 2 13 No
oral
20 A 30 F Ms Extra- 47 Day 1 7 14 No
oral
21 B 11 M Mn Extra- 85 Day 1 5 11 No
oral
22 B 50 M C Intra-oral 23.24 Day 1 3 7 Pseudomonas
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23 B 38 M B Intra-oral 17 Day 1 3 10 Contaminants

24 B 45 M Ms Extra- 36 Day 1 2 15 No
oral
25 B 12 M B Extra- 46 Day 1 2 10 No
oral
26 B 34 M B Intra-oral 38 Day 1 2 7 No
27 B 30 F B Intra-oral 47,48 Day 1 2 7 No

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28 B 26 F B Intra-oral 46 Day 1 2 7 No
29 B 22 F B Intra-oral 36 Day 1 2 7 No
30 B 43 M B Intra-oral 47,48 Day 1 2 7 No

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31 B 16 M B Intra-oral 26 Day 1 3 7 Streptococcus
constellatus
32 B 16 M B Intra-oral 47 Day 1 3 7 Streptococcus

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33 B 25 M B Intra-oral 36 Day 1 5 13 No
34 B 28 M Ms Extra- 38 Day 1 5 15 Actinobactor sp
oral

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35 B 32 F Ms Intra-oral 48 Day 3 3 17 Contaminants
36 B 10 F Ms Extra- 75 Day 3 3 7 No
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oral
37 B 37 F Ms Intra-oral 48 Day 10 7 15 Eschirichia coli
38 B 32 M Ms Intra-oral 48 Day 3 3 7 No
39 B 45 F B Extra- 15,16,1 Day 1 3 7 No
M

oral 7
40 B 24 F Ms Extra- 37 Day 1 5 9 No
oral
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Abbreviations used: M = male; F = female; Md = submandibular; B = buccal; C = canine; Ms =

submasseteric; Mn = submental; CST = microbial culture and antibiotic testing.
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