Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis Following Lower Third Molar Extraction: A Three-Arm Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Incidence of Alveolar Osteitis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded to group allocation. Placebo tablets and placebo gel will be used to maintain blinding.
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Amoxicillin Group
Participants will receive amoxicillin as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding.
干预措施: Amoxicillin (Drug)
Chlorhexidine Control Group
Participants will receive chlorhexidine as the control intervention following lower third molar extraction. Placebo tablets will be provided to maintain double blinding.
干预措施: Chlorhexidine (Drug)
Metronidazole Group
Participants will receive metronidazole as the assigned prophylactic intervention following lower third molar extraction. Placebo gel will be provided to maintain double blinding.
干预措施: Metronidazole (Drug)
结局指标
主要结局
Incidence of Alveolar Osteitis
时间窗: 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.
次要结局
- Postoperative Pain(Postoperative Day 3 and Day 7)
- Complications and Adverse Effects(Postoperative Day 3 and Day 7)
