Evaluation of Two Types of Matrix (Mucograft® and Mucoderm®) Associated With Coronally Advanced Flap for the Treatment of Single Gingival Recessions: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Percentage of defect coverage
研究概览
简要总结
The aim of this study is to evaluate clinically the results of two types of matrix (Geistlich Mucograft® and Mucoderm®) associated with CAF technique for the treatment of gingival recessions.
详细描述
This is a prospective, parallel and controlled clinical trial. The population that will be evaluated in the study will be selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.
Seventy-five patients presenting gingival recession will be divided in 3 groups:
- Group CAF + XDM (25): Periodontal surgery for root coverage through coronally advanced flap technique plus xenogenous dermal matrix graft Mucoderm®.
- Group CAF + MC (25): Periodontal surgery for root coverage through coronally advanced flap technique plus xenogenous collagen matrix graft Mucograft®.
- Group CAF (25): Periodontal surgery for root coverage through coronally advanced flap alone.
All surgeries will be performed by a single operator (MPS) at the dental clinic of ICT. Two horizontal incisions will be made at right angles to the adjacent interdental papillae, without interfering with gingival margins of neighboring teeth. Two oblique vertical incisions will be extended beyond the mucogingival junction and a trapezoidal mucoperiosteal flap will be raised up to the mucogingival junction. After, a split-thickness flap will be extended apically, releasing the tension and favoring coronal positioning of the flap. The exposed root surface will be scaled and planed. After the root planning procedures are performed, the epithelial layer from incised papillae will be removed to expose the connective tissue. After this, the group in which the participant is inserted will be revealed to the surgeon. The grafts will be used according to the producers' instructions. In the CAF + MD group, the matrix will be placed without previous hydration with saline solution, whereas in the CAF + XDM group the matrix will be hydrated with sterile saline for 10 minutes. In both grafts groups, the matrix will be cut into the desired dimensions to cover the entire surface of the root and around the bone, being positioned at the CEJ level. The matrix will be sutured independently of the flap, with the porous surface in contact with the tooth and bone, while the smooth surface will be facing the flap. Then, the flap will be coronally positioned and sutured to completely cover the graft. After the surgical procedure, the patients will receive the appropriate postoperative recommendations and sutures will be removed after 10 to 14 days of the surgical procedure.
Clinical parameters will be assessed at baseline and 3 and 6 months postoperatively.
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
- Double (Investigator, Outcomes Assessor)
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
- •Patients presenting Miller class I or II gingival recession in the maxillary canines or premolars;
- •Teeth included in the study should present pulp vitality and no associated with carious or cervical lesion;
- •Patients presenting no signs of active periodontal disease and full-mouth plaque and bleeding score ≤ 20%;
- •Probing depth ˂ 3 mm in the included and adjacent teeth, presenting no signs of bleeding or attachment loss;
- •Patients older than 18 years old;
- •Patients who agreed to participate and signed an informed consent form.
排除标准
- •Patients with systemic problems (cardiovascular, blood dyscrasias, immunodeficiency, and diabetes, among others) that will contraindicate the surgical procedure;
- •Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- •pregnant or lactating women;
- •Patients who underwent periodontal surgery in the area of interest;
- •Patients with orthodontic therapy in progress.
结局指标
主要结局
Percentage of defect coverage
时间窗: 6 months
Percentage mean (%) of root surface covered by the surgical treatment, measured through a periodontal probe.
次要结局
- Root coverage esthetic score(6 months)
- Evaluation of patient recovery through the report of discomfort and postoperative pain(7 days)
- Aesthetic evaluation according to patient through Visual Analog Scale (EVA)(6 months)
- Evaluation of root dentine hypersensitivity with the air blow test(6 months)
研究者
Mauro Pedrine Santamaria
Assistant Professor
Universidade Estadual Paulista Júlio de Mesquita Filho