Coronally Advanced Flap and Envelope Type of Flap Plus Acellular Dermal Matrix Graft for the Treatment of Thin Phenotype Multiple Recession Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Complete root coverage
研究概览
简要总结
Clinical evaluation of conventional and modified coronally advanced flaps combined with acellular dermal matrix graft
详细描述
The aim of this study was to evaluate the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I&II ≥3 mm) treated with coronally advanced flap (CAF) and acellular dermal matrix graft (ADMG) in 22 eligible participants.
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 (Participant)
盲法说明
A computer program was used to randomize 22 volunteers to treatment groups by a person who was not involved in the study. The result of this randomization process was written on a paper and then put in the sealed opaque envelope by a blinded examiner, in which the treatment procedure for the specific patient was defined. The envelope was opened by surgeon, immediately before starting the surgical procedure.
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
- •Systemically healthy patients
- •Miller Class I & II multiple buccal recession defects ≥ 3 mm on maxillary incisors, canines or premolars
- •Esthetic indication for root coverage
- •Probing depth < 3mm at the recession sites
排除标准
- •Pregnancy
- •Bruxism and occlusal trauma
- •Previous root coverage procedure
- •Endodontically treated teeth at the recession sites
- •Caries or restorations at the recession sites
- •Use of antibiotics over the previous 3 months prior to treatment
研究组 & 干预措施
Coronally advanced flap and acellular dermal graft
In CAF group, after local anesthesia oblique beveled vertical incisions were made at the most mesial and distal line angles of the recessions. These two incisions were connected with an intra-sulcular and interdental sub-marginal incisions in order to create the external surgical papillae. Then the flap was elevated as a split-full-split approach. The apical portion of the flap was reflected as close to the periosteum as possible by mesio-distal and apical sharp dissection parallel to the mucosa to release residual muscle tension and extended beyond the muco-gingival junction to facilitate the passive coronal replacement of the flap over the defects. In both groups ADMG was used as a sub-epithelial graft considering the manufacturer's instructions. The graft was positioned at the level of cemento-enamel junction and extended to the surrounding bone in the apical direction with full closure of the exposed root surfaces.
干预措施: Modified coronally advanced flap and acellular dermal matrix graft (Procedure)
Modified coronally advanced flap and acellular dermal graft
Test group received CAF avoiding vertical releasing incisions (mCAF).
干预措施: Modified coronally advanced flap and acellular dermal matrix graft (Procedure)
结局指标
主要结局
Complete root coverage
时间窗: 12 months
Complete defect coverage was calculated as the percentage of patients with defects having complete coverage achieved as the gingival margin at cemento-enamel junction or coronal level.
Root coverage esthetic score
时间窗: 12 months
Root coverage esthetic score (RES) was used as a scoring system to assess the esthetic outcomes following root coverage procedures on Miller Class I \& II gingival recession defects through the evaluation of clinical cases. Gingival margin level, marginal tissue contour, soft tissue texture, mucogingival junction alignment and gingival color were evaluated without magnification. Zero, 3 and 6 points were used for the evaluation of the position of the gingival margin, whereas a score 0 or 1 point was used for each of the other variables.
Patient satisfaction score
时间窗: 12 months
Each patient was questioned about his/her satisfaction with regard to the following patient-centered criteria: Root coverage attained, relief from dentinal hypersensitivity, color of gums, shape and contour of gums, surgical procedure in terms of pain during surgery and the discomfort experienced related to the duration of the procedure and handling by the operator, post surgical phase in terms of the pain, swelling, and postoperative complications; and cost effectiveness in terms of the time and money spent for the treatment. Patient satisfaction was assessed using a three-point rating scale: fully satisfied (3 points); satisfied (2 points); and unsatisfied (1 point).
次要结局
- Plaque Index(12 months)
- Gingival Index(12 months)
- Bleeding on Probing(12 months)
- Probing Depth(12 months)
- Clinical Attachment Level(12 months)
- Recession Depth(12 months)
- Recession Width(12 months)
- Gingival Thickness(12 months)
- Keratinized Tissue Width(12 months)
研究者
Cavid Ahmedbeyli
Associate Professor
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors