Comparison of the outcomes of using connective tissue graft versus volume-stable collagen matrix with modified coronally advanced flap for the treatment of multiple adjacent gingival recessions: A randomized clinical trial with molecular analysisâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare and evaluate effectiveness of connective tissue graft and volume-stable collagen matrix with modified coronally advanced flap procedure in terms of
研究概览
简要总结
Gingival recession is a highly prevalent condition which results in exposure of root surface to the oral environment. It is usually associated with impaired aesthetics, hypersensitivity, tooth structure loss (root caries and non-carious cervical lesions) and difficulty in plaque control. Various surgical techniques have been proposed for the treatment of gingival recession. For most of the soft-tissue augmentation surgeries, adjunctive use of CTG is deemed as the gold standard treatment. However, its harvesting is often associated with increased patient morbidity and risk of postoperative complications. Researchers have been continually attempting to develop new biomaterials to overcome these limitations. A newly developed volume-stable collagen matrix (VCMX) has recently been introduced. However, at present it remains unknown to what extent VCMX may represent a valuable alternative to CTG in treatment of multiple GRs. Also, knowledge about influence of VCMX on early and late wound healing events in root coverage procedures is currently missing. Our study will determine the clinical efficacy of VCMX in treatment of multiple GRs and also assess the healing dynamics at molecular level through evaluation of angiogenic and wound healing biomarkers expressed in gingival crevicular fluid (GCF).
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a) systemically healthy individuals b) Healthy periodontium or demonstrating stable periodontal condition following conventional periodontal therapy c) Full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) of < 15% d) No history of previous periodontal surgery at experimental sites e) Presence of at least two adjacent Cairo RT1 (gingival recession with no loss of interproximal attachment) multiple buccal recessions ≥ 2 mm on anterior teeth or premolars in both jaws f) Presence of an identifiable CEJ (a step ≤1 mm at CEJ level and/or presence of a root abrasion, but with an identifiable CEJ, will be accepted).
- •g) Probing depth (PD) ≤ 3 mm h) Absence of non-vital, supraerupted or mobile teeth for treatment of gingival recession.
排除标准
- •a) Molars and teeth with presence of restorations, caries or crowns in the area to be treated.
- •b) Gingival recessions presenting minimal amount (<1 mm) of keratinized tissue (KT) apical to recession area.
- •c) Pregnant and lactating females d) Smokers or tobacco usage in any form e) History of any systemic medication in last 3 months f) Patients with coagulation disorders.
结局指标
主要结局
To compare and evaluate effectiveness of connective tissue graft and volume-stable collagen matrix with modified coronally advanced flap procedure in terms of
时间窗: Baseline, 1 month, 3 months, 6 months
gingival recession depth reduction and soft tissue thickness gain after either treatment.
时间窗: Baseline, 1 month, 3 months, 6 months
次要结局
- Objective assessment of aesthetic outcome using root coverage esthetic score (RES)(To assess any differences in patient- centered outcome in terms of postsurgical pain till 1 week and dentinal hypersensitivity and aesthetic satisfaction.)
- To assess revascularization and wound healing dynamics through expression of specific biomarkers in GCF(Baseline (prior to surgery), and at 7, 14, 28, 90 and 180 days after the treatment)