Comparative Evaluation of rhPDGF- BB With Modified Coronally Advanced Tunnel and CTG Versus Modified Coronally Advanced Tunnel With CTG Alone for Root Coverage in Multiple Mandibular Gingival Recession Defects- A RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- Gingival recession depth (GRD)
研究概览
简要总结
The present study is a human, prospective, single centre, single blind, comparative controlled randomized clinical trial for the treatment of Miller's Class I, II or combination of class I and II mandibular recession and comparing the clinical outcomes prior to and 6 months after treatment. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
24 recession defects were selected in patients who were systemically and periodontally healthy, satisfying the determined inclusion criteria. Patients with at least two or more teeth having Miller's class I , II or combination of class I and II mandibular recession defects were included in the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.
The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.
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 (Outcomes Assessor)
盲法说明
Computer generated randomization sequence was obtained by the assistant. Allocation concealment was achieved using a sealed coded opaque envelope containing the treatment of the specific subject The sealed envelope containing treatment assignment was opened immediately prior to surgery to prevent surgeon bias
入排标准
- 年龄范围
- 21 Years 至 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •* Patients fulfilling the following criteria were included in the study:-
- •* Two or more teeth with Miller's class I and II or combined class I and II recession defects in mandibular anteriors.
- •* Age group 21-58 years.
- •* Patients with healthy or treated periodontal conditions.
- •* Patients willing to participate in the study.
- •* Absence of uncontrolled medical conditions.
- •* Patients with full mouth plaque score \0.8mm
排除标准
- •Pregnant or lactating females.
- •Tobacco smoking.
- •Uncontrolled medical conditions.
- •Untreated periodontal conditions.
- •Use of systemic antibiotics in the past 3 months.
- •Patients treated with any medication known to cause gingival hyperplasia.
- •Drug and alcohol abuse
- •No occlusal interferences.
- •Patient with a known hypersensitivity to rhPDGF-BB.
研究组 & 干预措施
Test group - rhPDGF-BB+MCAT+CTG
Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The test group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB
干预措施: root coverage (Procedure)
Control group - MCAT+CTG
Root coverage surgical procedure.The patients were assigned into two treatment groups (test and control). Intervention - The control group recession coverage is treated with modified coronally advanced tunnel with connective tissue graft alone
干预措施: root coverage (Procedure)
结局指标
主要结局
Gingival recession depth (GRD)
时间窗: 6 months
measured as the distance from the Cemento Enamel Junction to the gingival margin
2. Gingival Recession Width (GRW)
时间窗: 6 months
measured as the distance between the mesial gingival margin and distal gingival margin
Mean root coverage(MRC)
时间窗: 6 months
(Baseline recession depth - 6 month recession depth/Baseline recession depth)\*100
Complete root coverage(CRC)
时间窗: 6 months
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
coverage esthetic score(RCES)
时间窗: 6 months
The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES) Five Variables evaluated which are as follows: 1. Level of Gingival margin (GM) 2. Marginal Tissue Contour (MTC) 3. Soft Tissue Texture (STT) 4. Mucogingival Junction(MJ) alignment 5. Gingival Colour (GC)
次要结局
- probing pocket depth (PD)(6 months)
- clinical attachment level (CAL)(6 months)
- width of keratinized tissue (KTW)(6 months)