An interventional study of Amoxicillin and Metronidazole in Alveolar Osteitis, sponsored by Khyber Medical University Peshawar. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Prevention
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.
Alveolar osteitis, commonly known as dry socket, is a frequent postoperative complication following lower third molar extraction and may cause significant pain and delayed healing. This study will compare the efficacy of amoxicillin, metronidazole, and chlorhexidine in preventing alveolar osteitis following lower third molar extraction.
This is a three-arm, double-blinded randomized controlled trial to be conducted at the Department of Oral and Maxillofacial Surgery, Khyber College of Dentistry, Peshawar. Patients aged 18-40 years who require extraction of an impacted or partially erupted mandibular third molar under local anesthesia and meet the study eligibility criteria will be considered for participation.
Eligible participants who provide written informed consent will be randomly allocated to one of three groups: Group A will receive amoxicillin, Group B will receive metronidazole, and Group C will receive chlorhexidine as the control intervention. A computer-generated randomization sequence and sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. Placebo tablets and placebo gel will be used to maintain blinding of participants and outcome assessors.
Following extraction, participants will receive standardized postoperative instructions according to their assigned intervention. Participants will be assessed on Days 3 and 7 following extraction. A blinded assessor will evaluate the extraction site for alveolar osteitis using Blum's criteria. The presence or absence of alveolar osteitis will be recorded as a binary outcome. Postoperative pain will also be assessed using a Visual Analogue Scale, and additional postoperative complications or adverse effects will be documented.
The primary objective is to compare the incidence of alveolar osteitis among patients receiving prophylactic amoxicillin, metronidazole, or chlorhexidine following lower third molar extraction. The overall comparison among the three groups will be performed using the Chi-square test, with Fisher's exact test used when appropriate. Planned pairwise comparisons will include amoxicillin versus chlorhexidine, metronidazole versus chlorhexidine, and amoxicillin versus metronidazole, with Bonferroni correction for multiple comparisons.
46 studies on the registry are indexed under Dry Socket; 10 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 41 interventional studies indexed under Dry Socket.
Browse Dry Socket studies →Khyber Medical University Peshawar is the lead sponsor of 54 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants will receive chlorhexidine as the control intervention following lower third molar extraction. Placebo tablets will be provided to maintain double blinding.
Drug: Chlorhexidine
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.
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.
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.
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.
Time frame: Postoperative Day 3 and Day 7
Postoperative Pain
Postoperative pain will be assessed using a Visual Analog Scale (VAS) with mild level (0-3), moderate level (3-7), and severe level(7-10) of pain following lower third molar extraction. Pain scores will be recorded and compared among the three study groups.
Time frame: Postoperative Day 3 and Day 7
Complications and Adverse Effects
Complications and adverse effects following lower third molar extraction and administration of the assigned intervention will be assessed and recorded.
Time frame: Postoperative Day 3 and Day 7
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication will be made available to qualified researchers upon reasonable request, subject to applicable ethical, institutional, and data protection requirements. The shared data may include de-identified demographic and clinical characteristics, treatment-group allocation, alveolar osteitis outcomes, postoperative pain scores, and recorded complications or adverse effects.
Supporting information: Study protocol, Statistical analysis plan
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Amoxicillin · Metronidazole
Khyber Medical University Peshawar