Khyber College of Dentistry, Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
NCT Number: NCT07833176
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.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dr Sana Mushtaq, BDS, FCPS
CONTACT
Dr Syed Muaz Masoom Shah, BDS, MHR
CONTACT
Khyber Medical University Peshawar
Other
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis Following Lower Third Molar Extraction: A Three-Arm Double-Blinded Randomized Controlled Trial
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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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