Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis

NCT07833176 | Not Yet Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2026/13
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis (dry socket) following lower third molar extraction. Participants will be randomly assigned to one of three groups: amoxicillin, metronidazole, or chlorhexidine. Participants will be assessed on Days 3 and 7 after extraction for the presence or absence of alveolar osteitis and postoperative pain. The study will determine whether there is a difference in the incidence of alveolar osteitis among the three treatment groups.

Conditions

Alveolar Osteitis

Keywords

Alveolar osteitis; Molar extraction; Postoperative pain; Dry socket

Outcome Measures

Primary Outcomes (1)

• Incidence of Alveolar Osteitis

  Alveolar osteitis will be assessed as a binary outcome (yes/no) following lower third molar extraction. The incidence of alveolar osteitis will be compared among the amoxicillin, metronidazole, and chlorhexidine groups.

  Postoperative Day 3 and Day 7

Secondary Outcomes (2)

• Postoperative Pain

  Postoperative Day 3 and Day 7

• Complications and Adverse Effects

  Postoperative Day 3 and Day 7

Study Arms (3)

Amoxicillin Group

EXPERIMENTAL

Participants will receive amoxicillin as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding.

Drug: Amoxicillin

Metronidazole Group

EXPERIMENTAL

Participants will receive metronidazole as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding.

Drug: Metronidazole

Chlorhexidine Control Group

ACTIVE COMPARATOR

Participants will receive chlorhexidine as the control intervention following lower third molar extraction. Placebo tablets will be provided to maintain double blinding.

Drug: Chlorhexidine

Interventions

Amoxicillin DRUG

Amoxicillin will be administered as the prophylactic intervention to participants assigned to the amoxicillin group following lower third molar extraction. Placebo gel will be provided to maintain double blinding.

Amoxicillin Group

Metronidazole DRUG

Metronidazole will be administered as the prophylactic intervention to participants assigned to the metronidazole group following lower third molar extraction. Placebo gel will be provided to maintain double blinding.

Metronidazole Group

Chlorhexidine DRUG

Chlorhexidine will be administered as the control intervention to participants assigned to the chlorhexidine group following lower third molar extraction. Placebo tablets will be provided to maintain double blinding.

Chlorhexidine Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 40 years.
• Patients requiring non-surgical extraction of impacted or partially erupted mandibular third molars under local anesthesia.
• Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
• Patients who provide written informed consent to participate in the study.

You may not qualify if:

• Known allergy or drug hypersensitivity reaction to amoxicillin or metronidazole.
• Patients presenting with active infection at the extraction site, evidenced by pus discharge.
• Periodontally compromised (Grade 1) tooth.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Khyber College of dentistry: collaborator

Study Sites (1)

Khyber College of Dentistry, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (7)

• Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.

  PMID: 26946211 BACKGROUND

• Bergdahl M, Hedstrom L. Metronidazole for the prevention of dry socket after removal of partially impacted mandibular third molar: a randomised controlled trial. Br J Oral Maxillofac Surg. 2004 Dec;42(6):555-8. doi: 10.1016/j.bjoms.2004.06.015.

  PMID: 15544888 BACKGROUND

• Wright C, Mistry V, Smyth J, Saik WN, Innes N, Lamont T. The use of chlorhexidine in the prevention of alveolar osteitis after third molar extractions. Evid Based Dent. 2018 Mar 23;19(1):18-19. doi: 10.1038/sj.ebd.6401289.

  PMID: 29568017 BACKGROUND

• Babar A, Ibrahim MW, Baig NJ, Shah I, Amin E. Efficacy of intra-alveolar chlorhexidine gel in reducing frequency of alveolar osteitis in mandibular third molar surgery. J Coll Physicians Surg Pak. 2012 Feb;22(2):91-4.

  PMID: 22313644 BACKGROUND

• Freudenthal N, Sternudd M, Jansson L, Wannfors K. A double-blind randomized study evaluating the effect of intra-alveolar chlorhexidine gel on alveolar osteitis after removal of mandibular third molars. J Oral Maxillofac Surg. 2015 Apr;73(4):600-5. doi: 10.1016/j.joms.2014.08.035. Epub 2014 Sep 16.

  PMID: 25622882 BACKGROUND

• Teshome A. The efficacy of chlorhexidine gel in the prevention of alveolar osteitis after mandibular third molar extraction: a systematic review and meta-analysis. BMC Oral Health. 2017 May 19;17(1):82. doi: 10.1186/s12903-017-0376-3.

  PMID: 28526078 BACKGROUND

• Ramos E, Santamaria J, Santamaria G, Barbier L, Arteagoitia I. Do systemic antibiotics prevent dry socket and infection after third molar extraction? A systematic review and meta-analysis. Oral Surg Oral Med Oral Pathol Oral Radiol. 2016 Oct;122(4):403-25. doi: 10.1016/j.oooo.2016.04.016. Epub 2016 May 11.

  PMID: 27499028 BACKGROUND

MeSH Terms

Conditions

Dry Socket; Pain, Postoperative

Interventions

Amoxicillin; Metronidazole; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Biguanides; Guanidines; Amidines

Study Officials

• Danish Khan, BDS*

  Khyber College of dentistry

  PRINCIPAL INVESTIGATOR

• Dr Sana Mushtaq, BDS, FCPS

  Khyber College of dentistry

  STUDY DIRECTOR

• Dr Syed Muaz Masoom Shah, BDS, MHR

  Khyber College of dentistry

  PRINCIPAL INVESTIGATOR

• Dr Braikhna Murad, BDS, FCPS

  Khyber College of dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Sana Mushtaq, BDS, FCPS

CONTACT

+923349249676; sana.mushtaq@kcd.edu.pk

Dr Syed Muaz Masoom Shah, BDS, MHR

CONTACT

+923339299120; muazmasoom.shah@kcd.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Placebo tablets and placebo gel will be used to maintain blinding.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm, parallel-group, double-blinded randomized controlled trial comparing amoxicillin, metronidazole, and chlorhexidine for prevention of alveolar osteitis following lower third molar extraction.

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 22, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available after publication of the study results and will remain available for a period of 5 years.
• Access Criteria: Data will be available to qualified researchers for scientifically valid research purposes upon reasonable request. Requests will be reviewed by the study investigators and/or the relevant institutional authority. Data will be provided only after confirmation of appropriate ethical approval and compliance with applicable data protection and confidentiality requirements.

Locations

PA (1)