Effects of Simvastatin in the Prevention of Pain Experienced After Tooth Extraction. Double-blind Clinical Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.
研究概览
简要总结
Atraumatic extraction of maxillary premolar teeth (on the Right, left side) was done; Subsequently, the patients were randomly divided into two equal groups: A group (Extraction + filled with a Simvastatin solution impregnated gelatin sponge) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), were placed in one of the sockets; the pain level is recorded according to the VAS scores at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes, 6 hours, 12 hours and 24 hours.
详细描述
The method of procedure was performed by the same surgeon under local anesthesia (Lidocaine 2% with epinephrine 1:100,000, made by Darou Pakhsh Pharmaceutical Co; Tehran-Iran) to avoid bias. All two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. It must be noted that A group (Extraction + Simvastatin filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This event was a double-blind study (neither the patients nor the clinicians were aware of the rinsing solution used). Consequently, all periods of treatment, clinical parameters were recorded by an examiner who was blinded to the kind of medication received by the subjects while another clinician gave treatment.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients Age group 18-35 years Sulcular probing not more than 3 mm and no redness The determination for extraction of teeth (two maxillary first premolars)for orthodontic treatment A tooth requiring an atraumatic extraction technique.
排除标准
- •Systemic diseases Smoking habits; pregnancy or breastfeeding Periodontitis; Teeth having radiographically obvious large periapical Lesion(abscess/granuloma/cyst) T the history of Chemotherapy Radiation therapy Periodontal and the use of any medicine (antibiotics; steroids; non-steroidal anti-inflammatory drugs Allergy to Simvastatin.
研究组 & 干预措施
A (Simavastatin 10 mg with gelatin sponge graft)
A group: After atraumatic extraction, filled the tooth socket with Simvastatin10 mg solution impregnated gelatin sponge.
干预措施: Extraction + filled with Simvastatin solution impregnated gelatin sponge (Drug)
B(Gelatin sponge graft )
B group: Following atraumatic extraction, put in the tooth socket with gelatin sponge.
干预措施: Extraction + filled with Simvastatin solution impregnated gelatin sponge (Drug)
结局指标
主要结局
Pain experienced by patients following the atraumatic tooth extraction, evaluated by using a visual analog pain scale within 24 hours.
时间窗: one day
The pain level is recorded according to the visual analogue scale (VAS) at the intervals of before treatments, also Postoperative analog pain scores were assessed in 30 minutes to 24 hours later.
次要结局
未报告次要终点
研究者
Amirhossein Farahmand
director,clinical research
Islamic Azad University, Tehran