Salivary Bmp-2 Levels And Radiographic Measurement Of Bone Density At Extracted Tooth Socket In Patients With And Without Topical Application Of Simvastatin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bone Density
研究概览
简要总结
Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density were evaluated At Extracted Tooth Socket in patients With & Without topical Application Of Simvastatin
详细描述
Objective
The objective of this study was to compare:
'The salivary BMP-2 levels in the experimental and the control groups with and without topical simvastatin application on wound of extracted tooth socket.
The bone density at extracted tooth socket by measuring mean gray value from Intra oral periapical (IOPA) radiographs in the experimental and the control groups.
Method: Twenty four patients either male or female without any systemic disease, aged between 18 years to 25 years were selected. The patients were equally divided by random computer generated numbers into experimental and control groups. In the experimental group, tooth extraction was followed by placement of simvastatin (containing 10 mg of drug). In the control group, only tooth extraction was done. Saliva sample was collected from patients on days 0, 3, 7 and 40 and levels of salivary biomarker BMP-2 were measured with the ELISA technique. IOPA radiographs were taken on days 0 and 40 to determine the bone density by measuring mean gray values with the help of ImageJ software. The data was entered in SPSS version 25 and analyzed. P-value of ≤ 0.05 was considered as statistically significant.
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
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both male and female patients with permanent dentition, age (18 years to 25 years) were considered.
- •Patients undergoing extraction of maxillary or mandibular Pre molars for orthodontic procedure.
- •Teeth which required only simple non surgical extraction only under local anesthesia.
排除标准
- •Subjects taking antibiotics or non-steroidal anti inflammatory drugs (NSAIDS) within one week.
- •Patients with oral mucosal lesions (leukoplakia, erythroplakia, lichen planus).
- •Patients with oral carcinoma.
- •Patients with xerostomia.
- •Previous history of radiotherapy or chemotherapy
- •Patient with known hypersensitivity to anti inflammatory drugs.
- •Diabetic patients.
- •Pregnant and lactating patients.
- •Patients with social habits such as cigarette smoking and alcohol consumption.
- •Teeth radiographically involved in any abscess/cyst/granuloma.
- •Teeth requiring open surgical transalveolar extraction.
研究组 & 干预措施
Simvastatin
Atraumatic Extraction and administration of SIMVASTATIN (10 mg tablet grounded and added with normal saline, with gelatin sponge as a transporter) into the socket.
干预措施: Simvastatin 10mg (Drug)
结局指标
主要结局
Bone Density
时间窗: At 40th day of study
Mean grey value were measured using imageJ software
Salivary BMP-2 Levels
时间窗: At 40th Day of study
Mean values were measured using ELISA technique
次要结局
未报告次要终点
研究者
Muhammad Mutahir Mehdi
M.Phil Oral Biology Trainee
Postgraduate Medical Institute, Lahore