Treatment of Multiple Gingival Recessions With Collagen Matrix Versus Subepithelial Connective Tissue Graft: A Non-inferiority Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percentage of root coverage (RC)
研究概览
简要总结
Gingival recession (GR) is frequently associated with deterioration in dental esthetics and dental hypersensitivity. Outcomes from recent systematic reviews have demonstrated that when the root is covered and the gain in the width of keratinized tissue (KT) is expected, the use of subepithelial connective tissue grafts (SCTGs) associated with coronally advanced flaps (CAF) appears to be more predictable, and may be considered the gold standard procedure. However, the SCTGs may increase patients' morbidity (e.g., pain). This occurs because of the need for a donor surgical area, which may increase the risk of surgical complications like bleeding, as well as increases post-operative discomfort and the period of the surgical procedure. Another biomaterial, a new collagen matrix (CM) has been used as a substitute for the SCTG. The use of CM was associated with a significant reduction in post-operative morbidity, less post-operative pain and discomfort in the patient, and more esthetic satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patients will be included in the study if they fulfill the following inclusion criteria:
- •a clinical diagnosis of multiple-recession type defects at maxillary canines and premolars with at least one GR ≥ 3mm in depth;
- •areas of Miller's Class I or II GR;
- •teeth without root abrasions or caries.
排除标准
- •The exclusion criteria used will be as follows:
- •patients allergic to collagen
- •a history of smoking (within the previous 6 months)
- •pregnancy or lactation
- •a history of destructive periodontal disease or the formation of recurrent abscesses
- •root caries at the site of recession
- •previous surgical root coverage procedures
- •systemic healing disorders (for example, acquired immunodeficiency syndrome [AIDS], diabetes mellitus or risk factors evaluated by a medical doctor)
- •periodontal disease, or poor plaque control (full mouth plaque index > 20%).
- •The exclusion criteria for teeth will be:
- •noncarious cervical lesions (erosion, abfraction etc.)
- •any type of previous cervical restoration
- •giroversion
- •a prominent root surface.
研究组 & 干预措施
Collagen Matrix plus coronally advanced flap (CAF)
A new collagen matrix (Mucograft) associated to coronally advanced flap
干预措施: Coronally advanced flap (CAF) (Procedure)
Collagen Matrix plus coronally advanced flap (CAF)
A new collagen matrix (Mucograft) associated to coronally advanced flap
干预措施: Collagen Matrix (Drug)
Subepithelial connective tissue graft plus CAF
Subepithelial connective tissue graft associated to coronally advanced flap
干预措施: Coronally advanced flap (CAF) (Procedure)
Subepithelial connective tissue graft plus CAF
Subepithelial connective tissue graft associated to coronally advanced flap
干预措施: Subepithelial connective tissue graft (Procedure)
结局指标
主要结局
Percentage of root coverage (RC)
时间窗: 12-months
The primary clinical outcome will be percentage of root coverage (RC) at 12 months
次要结局
- Reductions in recession depth (RRD)(At the baseline, 3-month, 6-month and 12-months)
- Complete root coverage of the gingival recessions (CRC)(At the baseline, 3-month, 6-month and 12-months)
- Recession width (RW) at the cemento-enamel junction(At the baseline, 3-month, 6-month and 12-months)
- Relative clinical attachment level (RCAL)(At the baseline, 3-month, 6-month and 12-months)
- Probing depth (PD)(At the baseline, 3-month, 6-month and 12-months)
- keratinized tissue width (KT)(At the baseline, 3-month, 6-month and 12-months)
- Gain in thickness of gingival tissue (GT)(At the baseline, 3-month, 6-month and 12-months)
研究者
Giuseppe Alexandre Romito
Chairperson, Department of Periodontics
University of Sao Paulo