Coronally Advanced Flap With and Without Connective Tissue Graft for the Treatment of Single Maxillary Gingival Recession With Loss of Inter-dental Attachment. A Randomized Controlled Clinical Trial - 10 Years Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Complete Root Coverage (CRC)
研究概览
简要总结
Background: The aim of this randomized clinical trial (RCT) was to evaluate the adjunctive benefit of Connective Tissue Graft (CTG) to Coronally Advanced Flap (CAF) for the treatment of gingival recession associated with inter-dental clinical attachment loss equal or smaller to the buccal attachment loss (RT2). Material and Methods:The patients were randomly assigned to CAF+CTG (test group) or to CAF alone (Control group). Measurements were performed by a blind and calibrated examiner. Outcome measures included complete root coverage (CRC), recession reduction (RecRed), Root coverage Esthetic Score (RES), intra-operative and post-operative morbidity, and root sensitivity.
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
Two examiners, blinded with respect to the surgical procedures, assessed all the clinical and aesthetic outcomes of treatments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoking < 20 cigarettes/day.
- •Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) < 15% (measured at four sites per tooth).
- •Presence of at least one RT2 (Cairo et al. 2011) buccal gingival recession > 2 mm of depth
- •Only gingival recessions localized at upper central and lateral incisors, canine, and first and second pre-molars associated with aesthetic problems and/ordental hypersensitivity were considered.
- •Presence of an identifiable CEJ
排除标准
- •Systemic diseases or pregnancy.
- •Systemic antibiotic therapy in the last 6 months.
- •Active periodontal disease with sites showing probing depth >4 mm.
研究组 & 干预措施
CAF+CTG
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed.
A 1-2-mm-thick CTG was harvested using a single incision approach from the palate in the area between the second pre-molar and the second molar. The wound on the donor site of the palate was then sutured. The graft was positioned on the instrumented root surface immediately apical or at the level of the CEJ and then stabilized using a compressive crossing suture, anchored to the periosteum apical to the graft and closed with a palatal knot. The flap was coronally displaced 1-2 mm above the CEJ and sutured
干预措施: CAF+CTG (Other)
CAF
After local anaesthesia, a split-full-split thickness flap was elevated. The papillae adjacent to the involved tooth were then de-epithelialized. A gentle root debridement was performed. The flap was coronally displaced 1-2 mm above the CEJ and sutured
干预措施: CAF (Other)
结局指标
主要结局
Complete Root Coverage (CRC)
时间窗: After the intervention (10 years)
Complete Root Coverage: absence of gingival recession (Yes/No)
次要结局
- Recession Reduction (RecRed)(After the intervention (10 years))
- Root Coverage Aesthetic Score (RES)(After the intervention (10 years))
研究者
Dr. Francesco Cairo
Prof.
University of Florence