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NCT Number: NCT07833176

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khyber College of Dentistry, Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Incidence of Alveolar Osteitis

    Time frame: Postoperative Day 3 and Day 7

    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.

Secondary outcomes

  1. Postoperative Pain

    Time frame: Postoperative Day 3 and Day 7

    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.

  2. Complications and Adverse Effects

    Time frame: Postoperative Day 3 and Day 7

    Complications and adverse effects following lower third molar extraction and administration of the assigned intervention will be assessed and recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Sana Mushtaq, BDS, FCPS

CONTACT

[email protected]

+923349249676

Dr Syed Muaz Masoom Shah, BDS, MHR

CONTACT

[email protected]

+923339299120

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Khyber College of dentistry

Registry information

Official study title

Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis Following Lower Third Molar Extraction: A Three-Arm Double-Blinded Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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