Comparative Evaluation And Assessment Of Root Coverage Using Bovine Derived Collagen Matrix With Or Without Enamel Matrix Derivative: A Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recession Length And Width Measured In mm Measured By UNC-15 Periodontal Probe And
研究概览
简要总结
INTRODUCTION - Gingival recession is the apical migration of gingival edge to the junction of cementum and enamel (CEJ).Periodontal disease, plaque accumulations, inflammation, poor flossing, vigorous tooth brushing, are all potential causes of gingival recession. Due to the exposed dentin, gingival recession may produce increased sensitivity.
AIM- The aim of the study will be to evaluate the efficacy of collagen matrix with or without enamel matrix derivative in recession coverage.
OBJECTIVES- Evaluation and comparison of the percentage gain in root coverage, increase in the length and width of recession, increase in width of keratinised gingiva with Collagen matrix and Enamel matrix derivative, and with Collagen matrix alone at baseline,1 month and 3 months post operatively.
METHODOLOGY- A total of 20 systemically healthy subjects with Miller’s Class I and Class II recession defect, aged between 18-55 years, will be selected for the study. Patients selected would be randomly divided into two groups:
Test Group: 10 recession defects would be covered with resorbable collagen matrix (Fix SofTi®) and enamel matrix derivative (Emdogain®).
Control Group: 10 recession defects would be covered with resorbable collagen matrix (Fix SofTi®) alone.
RESULT- Follow up at baseline, 1 and 3 months for assessment of clinical attachment level , increase in width of keratinized gingiva and gain in root coverage.
Data collected will be statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Presence of Millers Class 1 and Class 2 gingival recession defects in maxillary and mandibular arch 2 Subjects who are systemically healthy with no contraindication to periodontal surgery 3 No previous history of periodontal therapy at the affected teeth 4 Evidence of patients ability to perform good plaque control.
排除标准
- •1 Subjects having any deleterious habits such as smoking or tobacco chewing 2 Subjects with history of any systemic disease 3 Recession defects associated with demineralization caries radiographic evidence of bone loss deep abrasion or restorations as well as teeth with evidence of pulpal pathology 4 Subjects showing unacceptable oral hygiene compliance during after Phase I therapy 5 Pregnant or lactating females 6 Subjects having undergone any periodontal therapy in the past three months 7 Subjects prescribed with steroidal chemotherapy radiotherapy.
结局指标
主要结局
Recession Length And Width Measured In mm Measured By UNC-15 Periodontal Probe And
时间窗: At 1 Month and 3 | Months
Vernier Caliper
时间窗: At 1 Month and 3 | Months
次要结局
- Clinical attachment level (in mm) measured by UNC-15 periodontal probe