The Effect of Vertically Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft Versus Coronally Advanced Flap With Sub-epithelial Connective Tissue Graft on Gingival Recession: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in recession depth (mm)
研究概览
简要总结
The aim of this randomized clinical trial will be to assess the change in recession depth after using a vertically coronally advanced flap with sub-epithelial connective tissue graft compared to a coronally advanced flap with sub-epithelial connective tissue graft after 6 months.
详细描述
To test new approaches for root coverage for the treatment of RT1 and RT2 gingival recession.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥ 18 years.
- •Systemically healthy.
- •Non-smokers.
- •Full-mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- •Presence of identifiable CEJ.
- •Absence of non-carious cervical lesions.
- •Mature permanent tooth in the aesthetic zone.
- •At least one recession defect type RT1 and/ or RT2 in the upper or lower jaw.
- •Thin gingival phenotype (GT < 0.8 mm) via probe transparency method.
- •A minimum of (2 mm KTW).
排除标准
- •Any systemic disease.
- •Pregnancy or lactation.
- •Cairo RT3 recession defects.
- •Teeth with active orthodontic treatment.
- •Previous periodontal surgery in the area.
- •Use of any drugs that might lead to gingival enlargement.
- •Caries, restoration, mobility, unstable endodontic condition, and malocclusion in teeth undergoing treatment.
研究组 & 干预措施
Coronally Advanced flap combined with sub-epithelial connective tissue graft
The combination of a SCTG with CAF was regarded as the gold standard for root coverage procedures
干预措施: Coronally Advanced flap combined with sub-epithelial connective tissue graft (Procedure)
Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft
Vertically coronally advanced flap combined with a subepithelial connective tissue graft for the treatment of gingival recession defects. The procedure involves preparation and coronal advancement of a vertically designed flap to cover the exposed root surface, followed by placement of a subepithelial connective tissue graft beneath the flap to enhance soft-tissue thickness and root coverage.
干预措施: Vertically Coronally Advanced flap combined with sub-epithelial connective tissue graft (Procedure)
结局指标
主要结局
Change in recession depth (mm)
时间窗: at Baseline and 6 months
Change in recession depth in millimeters will be measured using a UNC-15 periodontal probe as the distance from the cementoenamel junction towards the most apical extension of the gingival margin
次要结局
- Gingival Recession Width (mm)(at baseline and 6 months)
- Keratinized Tissue Width (mm)(at Baseline and 6 months)
- Keratinized Tissue Height (mm)(at Baseline and 6 months)
- Probing Depth (mm)(at Baseline and 6 months)
- Gingival Thickness (mm)(at Baseline and 6 months)
- Recession Reduction (mm)(at Baseline and 6 months)
- Clinical Attachment Level (mm)(at Baseline and 6 months)
- Complete Root Coverage (%)(at 6 months)
- Bleeding on Probing (+/-)(at Baseline and 6 months)
- Plaque Index (scores 0, 1, 2, 3)(at Baseline and 6 months)
- Post-Operative Pain (VAS) Visual Analogue Scale Questionnaire(Surgical day and days 1, 3, 7, and 14 after surgery)
- Patient Esthetic Satisfaction (RES) Root Coverage Esthetic Score(at 6 months)
- Mean Percentage of Root Coverage (mRC) %((subtraction of gingival RD at baseline from gingival RD at 6 months divided by gingival RD at baseline) multiplied by 100)
研究者
Mai Magdy Abu El Eneen
Principal Investigator
Cairo University