Improvement of Surgical Approaches for the Management of Gingival Recessions in Patients After Orthodontic Treatment
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Complete root coverage (CRC)
研究概览
简要总结
Modification of the periodontal soft tissue phenotype and coverage of exposed root surfaces in patients who have undergone orthodontic treatment.
详细描述
This study aims to determine and implement the optimal treatment approach for gingival recession defects (GRDs) developing during orthodontic therapy through a comparative analysis of different surgical treatment techniques. It also aims to explore the key aspects of managing GRDs and sites with inadequate keratinized gingiva in orthodontic patients, including risk assessment, diagnosis, treatment indications, the role of soft tissue phenotype modification, the progression of gingival recession during orthodontic tooth movement, and the optimal sequencing of periodontal and orthodontic therapies to achieve stable functional and esthetic outcomes.
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 total of 75 participants will be randomly allocated to the treatment groups using a computer-generated randomization sequence by an independent individual not involved in the study. Allocation concealment will be ensured through the use of sequentially numbered, sealed, opaque envelopes. Each envelope will contain the assigned treatment for a specific participant. Both the participants and the investigator will remain blinded to the group allocation prior to the surgical intervention. The envelope will be opened by the surgeon immediately before the procedure, at which point the assigned technique will be revealed. Outcome assessment will be performed by an independent examiner blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients
- •RT1 and RT2 gingival recession defects according to the Cairo classification, with recession depth ≥ 2 mm
- •Completed orthodontic treatment
- •Aged between 18 and 70
排除标准
- •Pregnancy
- •Poor adherence to oral hygiene practices
- •Refusal to participate in the study
研究组 & 干预措施
Group I: Coronally advanced flap and a de-epithelialized soft tissue graft.
Patients in Group I who have completed orthodontic treatment will receive a coronally advanced flap and a de-epithelialized soft tissue graft to modify the periodontal soft tissue phenotype and cover exposed root surfaces caused by gingival recession.Evaluation of the effectiveness of coronally advanced flap combined with a de-epithelialized soft tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm).
干预措施: Coronally advanced flap and a de-epithelialized soft tissue graft (Procedure)
Coronally advanced flap and Mucoderm soft tissue collagen graft.
Patients in Group III will receive a coronally advanced flap and a Mucoderm soft tissue collagen graft. Evaluation of the effectiveness of coronally advanced flap combined with a Mucoderm soft tissue collagen graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm). In all three groups, surgical interventions will be performed after completion of orthodontic treatment.
Gingival thickness will be evaluated before treatment and at 6 and 12 months postoperatively. Root coverage, esthetic parameters, and patient satisfaction will be assessed 12 months after treatment.
干预措施: Coronally advanced flap and Mucoderm soft tissue collagen graft (Procedure)
Coronally advanced flap and a subepithelial connective tissue graft.
Patients in Group II will receive a coronally advanced flap and a subepithelial connective tissue graft for the same purpose. Evaluation of the effectiveness of coronally advanced flap combined with a subepithelial connective tissue graft in the management of multiple gingival recessions (Cairo classification RT1 and RT2 ≥ 2 mm).
干预措施: Coronally advanced flap and a subepithelial connective tissue graft (Procedure)
结局指标
主要结局
Complete root coverage (CRC)
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 (RES)
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.
Mean root coverage
时间窗: 12 months
Mean root coverage refers to the average amount of exposed tooth root that becomes covered again by gum tissue after periodontal treatment for gum recession, calculated as a percentage or millimeters. It is used to evaluate how successful the treatment is in restoring gum coverage, improving aesthetics, and protecting the root surface.
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)
- Oral Health Impact Profile-14 (OHIP-14)(12 months)
研究者
Vafa Khanmammadova
Researcher
Aziz Aliyev Azerbaijan State Advanced Training Institute for Doctors