Coronally Advanced Flap With Xenogenic Collagen Matrix or Autogenous Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recessions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean Recession Reduction (RecRed)
研究概览
简要总结
The primary aim of this study is to evaluate whether the use of a xenogenic collagen matrix (XCM) for the treatment of multiple adjacent gingival recessions (MAGRs) with a multiple coronally advanced flap technique (mCAF) achieves better results than the use of an autologous connective tissue graft (CTG) in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding). The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM is not inferior to CTG in terms of recessions reduction and secondary clinical variables, and superior regarding to PROMs.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old and able to sign informed consent
- •At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
- •A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
- •Available to attend study related procedures (including follow-up visits)
排除标准
- •Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
- •Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
- •Pregnant or nursing women;
- •History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
- •Furcation involvement in the teeth to be included;
- •Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
- •Presence of fixed or removable prosthesis in the area to be treated
结局指标
主要结局
Mean Recession Reduction (RecRed)
时间窗: 6 months; 1 year
Mean changes in mm in recession depth between baseline and 1-year
次要结局
- Mean Root Coverage (MRC)(6 months; 1 year)
- Post-operative morbidity (pain, swelling, discomfort)(14 days)
- Keratinised tissue height (KTH) changes(6 months; 1 year)
- Complete Root Coverage (CRC)(6 months; 1 year)