"Prevention of Dry Socket by Means of Single Preoperative Oral Dose of Metronidazole and Amoxicillin Compared to Conventional Therapy"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- dry socket
研究概览
简要总结
Background: One of the commonest post-operative complications after tooth extraction is dry socket; it can be defined as postoperative pain in and around the tooth extraction site, which increases in severity at any time between 3rd to 5th post-operative days along with disintegrated blood clot within the tooth extraction socket with or without halitosis. The exact etiology is unclear therefor prevention remains the main beneficial therapy. Various factors are thought to play an important role in etiology of dry socket including, anaerobes, fibrinolysis, traumatic extractions, frequent spiting and rinsing, oral contraceptive pill and smoking.
Numerous approaches have been tried for prevention of dry socket; include antiseptic mouthwashes, anti-fibrinolytic agents, antibiotics, intra-socket dressings and medicated packing into the extraction wound for example chlorohexidine mouthwashes, warm saline rinses, gelatin sponges, occlusive dressings and oxidized cellulose sponge.
Purpose of the study is to compare the role of single preoperative oral dose of metronidazole with amoxicillin in hindrance of dry socket compared to conventional therapy after removal of mandibular third molar of class 2 impaction.
Objectives: To find out effective treatment for prevention of dry socket among preoperative single oral dose of metronidazole and amoxicillin compared to conventional therapy.
Methods: A double blind randomized control trial in which patients requiring surgical extraction of lower 3rd molar of class 2 impactions were selected for this study. Patients were randomly divided into 3 groups, one of the groups had received single preoperative oral dose of metronidazole one hour before extraction, second group was treated with single oral dose of amoxicillin an hour before tooth extraction and third group was treated with conventional therapy. Patients were asked to visit on 5th postoperative day or before it in case the pain persist or reoccur.
详细描述
Background Dry socket is one of the commonest problems that occur after extraction of molars. It can be described as a painful inflammatory condition that occurs due to non-formation or early displacement of a blood clot from a tooth extraction site before the healing of wound occurs. Clinical presentation of dry socket is intense ache, bad breath, hollow socket due to displacement of blood clot and exposure of bone. Pain produced by dry socket is known to last from 7 to 14 days. Incidence of dry socket is approximately 3% for routine extractions and can go beyond 30% for impacted lower third molars.
Tooth impaction is a pathological condition in which a tooth fails to erupt to the occlusal level of its normal position. Lower third molars are the most commonly impacted teeth. The prevalence of third molar impaction ranges from 16.7% to 68.6%.
Multiple factors are associated with dry socket formation. such as patient's age, Gender, extraction in posterior region of mouth, smoking status, oral contraceptive.
Incidence of dry socket perhaps lies somewhere from 5% to 20% worldwide.It ranges broadly between 0.9% and 21% in United Kingdom and 3.5% in Siri-Lankan. Incidence of dry socket in Pakistani population is reported 13.8%20.
Incidence of dry socket after extraction of impacted third molars is about 25-30%33.
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, Care Provider)
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 requiring surgical extraction of lower third molars with class 2 impaction.
- •Males and females were included.
- •Age range of the patients was between 18 to 40 years.
排除标准
- •Non-surgical extractions, extractions of other then lower molars,
- •Infected tooth.
- •tooth with grade 3 or greater mobility.
- •Reluctant to participate.
- •Pregnant ladies.
- •Nursing mothers.
- •Alcoholic patients.
- •Patients taking oral contraceptives.
- •Patient already taking antibiotics.
- •Allergic to amoxicillin and metronidazole.
- •Patients on anticoagulant therapy i.e. warfarin, nicoumalone, phenytoin, fluocil.
- •Those with severe renal and hepatic dysfunction.
研究组 & 干预措施
amoxicillin
single preoperative oral 500 mg dose of Amoxicillin before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos.
干预措施: Amoxicillin 500 Mg (Drug)
metronidazole
single preoperative oral 400 mg dose of metronidazol before extraction of lower 3rd molar and painkillers after extraction for 1st 48 hours then sos.
干预措施: metronidazole 400mg (Drug)
conventional group
conventional therapy for prevention of dry socket post operative; 400mg metrinidazol 3 times a day for 5 days 500mg of amooxicillin 2 times a day for 5 days painkiller 48 hours after extraction then sos
干预措施: metronidazol 400mg and amoxicillin 500mg (Drug)
结局指标
主要结局
dry socket
时间窗: 5 days
Characteristic of interest: patient complaining of moderate to severe pain in or around the tooth extraction site between 3 to 5 post-operative days. Measuring instruments: The observation will be performed with naked eye under the light of dental unit and cheek will be retracted via dental mirror instrument. Method of testing: Presence of moderate to severe pain, total or incomplete loss of blood clot, bare bone in the socket, and halitosis. Decision criteria: Presence of above features at the site of tooth extraction will indicate the presence of dry socket.
次要结局
未报告次要终点
研究者
Tahseen Shabbir Khooharo
postgraduate trainee
Dow University of Health Sciences