Comparison of the Effect of Immediate Post-Extraction Socket Irrigation With Normal Saline Versus Chlorhexidine on the Frequency of Dry Socket: A Single-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Frequency of Alveolar Osteitis (Dry Socket)
研究概览
简要总结
Dry socket, also called alveolar osteitis, is a painful complication that can occur after tooth extraction, particularly following removal of impacted lower wisdom teeth. It occurs when the blood clot that normally forms in the extraction socket is lost or breaks down, resulting in pain and delayed healing.
This study will compare two solutions used to irrigate the extraction socket immediately after removal of an impacted lower wisdom tooth: normal saline and chlorhexidine. The study will determine whether immediate socket irrigation with chlorhexidine reduces the frequency of dry socket compared with normal saline.
A total of 174 eligible patients undergoing surgical extraction of impacted lower wisdom teeth will be randomly assigned to receive either normal saline or chlorhexidine for immediate post-extraction socket irrigation. Participants will not be informed which irrigation solution they receive. The extraction will be performed by a single surgeon, and postoperative assessment will be performed by a co-researcher.
Participants will be assessed for signs and symptoms of dry socket on postoperative days 2, 3, and 5. The occurrence of dry socket will be determined using predefined clinical criteria, including pain, trismus, halitosis, gingival inflammation, exposed or bare bone, radiating pain, and ipsilateral lymphadenopathy.
The study will compare the frequency of dry socket between the chlorhexidine and normal saline groups. The findings may help determine whether chlorhexidine is more effective than normal saline for reducing the occurrence of dry socket after surgical extraction of impacted lower wisdom teeth.
详细描述
Alveolar osteitis, commonly known as dry socket, is a painful postoperative complication that may occur following tooth extraction. It is characterised by moderate to severe pain at the extraction site and may be associated with delayed healing and other local clinical signs. The condition generally develops within the first few days following extraction and may cause considerable discomfort to patients.
The development of alveolar osteitis has been associated with breakdown or loss of the blood clot within the extraction socket. Local fibrinolytic activity and bacterial factors have been proposed as contributing mechanisms. Surgical trauma, bacterial contamination and other patient- and procedure-related factors may increase the risk of alveolar osteitis.
Normal saline is commonly used for irrigation of extraction sockets after surgical tooth removal. Chlorhexidine has antimicrobial and antiseptic properties and has been investigated for its potential role in reducing the occurrence of alveolar osteitis. Previous studies have reported lower frequencies of dry socket following chlorhexidine use compared with saline or other postoperative measures. However, the effectiveness of immediate post-extraction socket irrigation with chlorhexidine compared with normal saline requires further evaluation in the local clinical setting.
This single-blinded randomized controlled trial will compare the effect of immediate post-extraction socket irrigation with chlorhexidine versus normal saline on the frequency of dry socket following surgical extraction of impacted lower wisdom teeth.
Eligible patients will be recruited from the Oral and Maxillofacial Surgery Department, CMH Medical College and Institute of Dentistry, Lahore. Participants will be adults aged 18-50 years who are classified as ASA physical status I or II and who require surgical extraction of impacted lower wisdom teeth with slight to moderate difficulty according to Pederson's scale.
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 will be unaware of their assigned socket irrigation solution. The outcome assessor will also be blinded to group allocation during postoperative assessment.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 50 years.
- •Patients requiring surgical extraction of an impacted lower third molar (lower wisdom tooth).
- •Impacted lower third molars classified as having slight to moderate difficulty according to Pederson's scale.
- •Patients classified as American Society of Anesthesiologists (ASA) physical status I or II.
- •Patients of either biological sex.
- •Patients who provide written informed consent to participate in the study.
排除标准
- •Systolic blood pressure ≥160 mmHg.
- •Diastolic blood pressure ≥100 mmHg.
- •Current smokers.
- •Alcohol use.
- •Patients with muscular diseases.
- •Patients currently taking antibiotics or anti-inflammatory medications.
- •Patients with physical or mental disabilities that would prevent participation in the study or completion of follow-up assessments.
- •Patients requiring extraction without bony osteotomy.
- •Deep or very difficult impactions according to Pederson's scale.
研究组 & 干预措施
Chlorhexidine Socket Irrigation
Participants allocated to the experimental group will undergo surgical extraction of an impacted lower third molar under local anaesthesia. Immediately after extraction, the extraction socket will be irrigated with chlorhexidine according to the study protocol, followed by socket closure with silk suture. Participants will receive the same postoperative instructions and medications as the comparator group. Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
干预措施: Chlorhexidine Socket Irrigation (Procedure)
Normal Saline Socket Irrigation
Participants allocated to the comparator group will undergo surgical extraction of an impacted lower third molar under local anaesthesia. Immediately after extraction, the extraction socket will be irrigated with normal saline according to the study protocol, followed by socket closure with silk suture. Participants will receive the same postoperative instructions and medications as the experimental group. Postoperative assessment for alveolar osteitis will be performed on days 2, 3, and 5.
干预措施: Normal Saline Socket Irrigation (Procedure)
结局指标
主要结局
Frequency of Alveolar Osteitis (Dry Socket)
时间窗: Postoperative days 2, 3, and 5
The frequency of alveolar osteitis (dry socket) will be assessed in participants following surgical extraction of an impacted lower third molar. Alveolar osteitis will be diagnosed when at least three predefined clinical criteria are present, including mild to severe postoperative pain, trismus, halitosis, inflamed or hyperaemic gingiva, exposed or bare bone with an empty socket, radiating pain to the ear or temporal region, and ipsilateral lymphadenopathy. The number and percentage of participants developing alveolar osteitis will be compared between the chlorhexidine and normal saline groups.
次要结局
- Postoperative Trismus(Postoperative days 2, 3, and 5)
- Postoperative Pain Intensity(Postoperative days 2, 3, and 5)
研究者
Mahnoor Rehman
Postgraduate Trainee
CMH Lahore Medical College and Institute of Dentistry