The Use of Simvastatin Gel With Perforated Resorbable Membranes in the Treatment of Intrabony Defects in Chronic Periodontitis Patients (Clinical and Biochemical Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Probing pocket depth
研究概览
简要总结
Modified perforated membrane (MPM) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (OM). Simvastatin (SMV) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. Ethylenediaminetetraacitic acid (EDTA) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. The investigators compared the clinical and radiographic outcome of SMV gel combined with MPM to SMV gel combined with OM with and without an associated EDTA gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. Moreover, evaluation of SMV gingival crevicular fluid (GCF) levels availability for 30 days in cases with and without EDTA root surface etching was performed.
详细描述
Forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% SMV gel and covering the defect with OM (Group I), open flap procedure, 1.2% SMV gel and covering the defect with MPM (Group II), open flap procedure, 24% EDTA root surface etching,1.2% SMV gel and then coverage of the defect by OM (Goup III), or open flap procedure, 24% EDTA root surface etching, 1.2% SMV gel and then coverage of the defect by MPM (Group IV). Plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy. Additionally, GCF was collected from group I, II, III and IV at 1,7,14, 21, and 30 days in order to evaluate SMV availability and the effect of EDTA root surface etching on its availability using High-performance liquid chromatography(HPLC).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were all healthy and free from any systemic disease.
- •No history of antibiotic therapy or periodontal treatment for at least six months preceding the study.
- •Patients were willing and able to return for multiple follow up visits.
- •Periodontal defects with
- •Probing depth > 5 mm.
- •Clinical attachment loss >4 mm.
- •Standardized radiographic evidence of interproximal intrabony defect using periapical radiograph.
- •Good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one).
排除标准
- •Pregnancy, lactation for female patients.
- •Smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines.
- •History of allergic reaction to the medications used.
- •Vulnerable groups and handicapped.
研究组 & 干预措施
Simvastatin/Occlusive membrane
open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
干预措施: Simvastatin (Drug)
Simvastatin/Occlusive membrane
open flap procedure, 1.2%simvastatin gel applied and covering the defect with resorbable collagen occlusive membrane .
干预措施: Occlusive membrane (Device)
Simvastatin/perforated membrane
open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
干预措施: Simvastatin (Drug)
Simvastatin/perforated membrane
open flap procedure, 1.2% simvastatin gel and covering the defect with resorbable collagen modified perforated membrane.
干预措施: Modified perforated membrane (Device)
EDTA/Simvastatin/Occlusive membrane
open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.
干预措施: Simvastatin (Drug)
EDTA/Simvastatin/Occlusive membrane
open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.
干预措施: EDTA (Other)
EDTA/Simvastatin/Occlusive membrane
open flap procedure, 24% EDTA root surface etching,1.2% simvastatin gel and then coverage of the defect with occlusive membrane.
干预措施: Occlusive membrane (Device)
EDTA/Simvastatin/perforated membrane
open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
干预措施: Simvastatin (Drug)
EDTA/Simvastatin/perforated membrane
open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
干预措施: EDTA (Other)
EDTA/Simvastatin/perforated membrane
open flap procedure, 24% EDTA root surface etching, 1.2% simvastatin gel and then coverage of the defect with modified perforated membrane.
干预措施: Modified perforated membrane (Device)
结局指标
主要结局
Probing pocket depth
时间窗: Baseline to 9 months
Probing pocket depth was measured from the free gingival margin to the base of the pocket from baseline to 6 months and 9 months
Clinical attachment level
时间窗: Baseline to 9 months
Clinical attachment level was measured from the cementoenamel junction to the base of the pocket from baseline to 6 months and 9 months
Plaque index
时间窗: Baseline to 9 months
Plaque index was measured from baseline to 6 months and 9 months
Gingival index
时间窗: Baseline to 9 months
Gingival index was measured from baseline to 6 months and 9 months
Linear measurements
时间窗: Baseline to 9 months
Linear measurements were measured using Digora software from baseline to 6 months and 9 months
Radiodensitometric measurements
时间窗: Baseline to 9 months
Bone density was measured using Digora software from baseline to 6 months and 9 months
次要结局
- Simvastatin gingival crevicular fluid levels(Day 1, 7, 14, 21 and 30)
研究者
Dalia Rasheed Issa
Associate lecturer of oral medicine and periodontology
Ain Shams University