Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess

This two-arm, parallel, comparative, observer blind, randomised study will be performed in adult subjects both male and female ≥18 years of age who present with acute odontogenic infection with or without abscess. A total of 472 subjects will be randomised in 1:1 ratio to get 205 evaluable subjects in each study arm. After obtaining informed consent, subject will undergo surgical intervention including surgical incisions, drainages, removal of the involved tooth, debridement, puncture lavage or trephination, if deemed necessary by the Investigator. These surgical interventions will be performed before the start of study treatment. On Day 0 after confirming the eligibility, subjects will be randomised to either of the study arms. The treatment duration of the study will be at least 5 days which may increase to 7 days, if Investigator feels the need of continuing the treatment at Day 5. In such cases clinical assessment will be done again at Day 7. Thus the efficacy evaluation will be performed at baseline (Day 0) prior to study drug administration and on Day 5 and/ or 7. Safety laboratory evaluations will be performed at Screening Visit and will be repeated at end of study treatment i.e. either on Day 5 or Day 7. On Baseline, Day 2, Day 5 and/ or Day 7, Visual Analogue Scale (VAS) will be used to measure amount of pain and swelling that a subject will experience. This scale has numerical ratings from 0 to 10. Zero would mean "No pain" and 10 would mean "Worst possible pain". The subject will be asked to choose the most appropriate score on VAS which best describes his/her pain status over last 24 hours. While using VAS for swelling, zero would mean "No swelling" and 10 would mean "Maximum possible swelling". The Investigator will choose the most appropriate score on VAS which best describes subject's swelling.

Sample for microbiological culture will be obtained at the discretion of Investigator while performing the surgical procedure. When microbiological culture is indicated and feasible, two sets (each consisting of aerobic and anaerobic media) will be obtained. This sampling will be done in approximately 80 subjects randomly who will provide consent at Screening. The sample will be collected and dispatched in appropriate transport medium to the central laboratory for culture and antibiotic susceptibility.

Protocol waivers or exemptions will not be allowed.

The total duration of each subject's participation will be 6-9 days including Screening period of 0-1 day (Day -1 to Day 0) and Treatment period of 5-7 days (Day 0 to Day 5-7).

The primary objective of the study is to compare clinical efficacy (cure and improvement) of both the treatment arms which uses VAS for assessment of pain and swelling. Since the clinical efficacy parameters are subjective, it is mandatory to keep the observer/Investigator blinded during the study assessment. In addition, designing blinded study is challenging owing to different dosage regimen and formulation of study drugs. The study design of double blind double dummy is not recommended in view of increased pill burden which in turn can have an impact on treatment compliance. The possibility of over-encapsulation is ruled out due to large pill size of amoxicillin + clavulanic acid. Therefore to maintain blinding of Investigators, the study is designed as observer blind with Investigator remaining blinded throughout the study period. An unblinded study team member will be appointed for each site who will be involved in dispensing of the study drugs to subjects. The unblinded study team member will remain present during subject assessment for all study visits and will ensure that Investigator remains blinded to treatment assignment.