NCT05563428招募中不适用
Efficacy of Free Gingival Graft Versus Connective Tissue Graft in the Treatment of Gingival Recessions at the Lower Incisors: a RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Digital mean root coverage
研究概览
简要总结
This study wil compare FGG and CTG for recession coverage in the anterior mandibula.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA type I and II subjects
- •Localized Gingival Recessions
- •Recessions Cairo RT I-II-III
- •FMPS < 10%
- •FMBS< 10%
- •<10 cigs/ day
- •No contra-indication against oral surgical interventions
- •Patient is able to give inform consent
排除标准
- •Infection (local or systemic). Each infection will be evaluated prior to study procedure for suitability. Patients with gingivitis or local infection (fracture, apical reaction) will undergo a dental treatment prior to entering the study. In case of systemic infection, the evaluation will be based on medical anamneses, and if necessary will be referred to relevant medical tests.
- •ASA type > II
- •Current pregnancy or breastfeeding women
- •Alcoholism or chronically drug abuse
- •Smokers, ≳ 10 cigarettes per day
- •Immunocompromised patients
- •Uncontrolled diabetes
- •Untreated periodontitis
- •History of previous periodontal surgery (mucogingival or other) on the teeth to be included
- •Presence of severe tooth malposition, rotation or significant version of the tooth to be treated
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of no-compliance or unreliability
结局指标
主要结局
Digital mean root coverage
时间窗: Baseline, 3 months, 6 months and up to 10 years after surgery
Defined as the percentage of root coverage in the mid-buccal aspect, taking baseline as a reference. Measured by dividing the mean surface (in mm²) of the root covered by the procedure by the mean surface (in mm²) of root exposed at baseline.
次要结局
未报告次要终点
研究者
Isabelle Laleman
Chef de clinique
Centre Hospitalier Universitaire de Liege
研究点 (2)
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