NCT07239180尚未招募不适用
Clinical Evaluation of Tunneled Coronally Advance Flap (TCAF) Versus Modified Coronally Advanced Tunnel With Connective Tissue Graft in Management of Single Recession Defects (RT2): A Randomized Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Gingival Recession Depth (GRD)
研究概览
简要总结
The technique under investigation aims to provide effective root coverage while offering the advantage of being less invasive.
详细描述
Limited RCTs have been found in the literature comparing the root coverage capacity of the tunneled coronally advanced flap versus modified coronally advanced tunnel combined with connective tissue graft in single RT2 defects. So, this trial aims to fill this gap of knowledge.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with single RT2 gingival recession defect ≥ 2 mm
- •Age >18 years old.
- •Systemically healthy patients with no contraindications for periodontal surgeries.
- •Gingival and plaque index less than 20%.
- •No previous surgeries at the defect site.
- •Accepts 6 months follow-up period (compliant patients).
排除标准
- •RT1 gingival recession.
- •Smokers >10 cigarettes a day a contraindicating for any plastic periodontal surgery.
- •Poor oral hygiene.
- •Active periodontitis patients.
- •Patients on medications causing gingival enlargement.
- •Pregnancy.
- •Teeth mobility ≥ 1 mm.
- •Patients using fixed or removable orthodontic appliances.
- •Restoration and/or periapical radiolucency at the defect site.
研究组 & 干预措施
Modified Coronally Advanced Tunnel with Connective Tissue Graft
Active Comparator
干预措施: Modified Coronally Advanced Tunnel with Connective Tissue Graft (Procedure)
Tunneled Coronally Advance Flap (TCAF) with Connective Tissue Graft
Experimental
干预措施: Tunneled Coronally Advance Flap with Connective Tissue Graft (Procedure)
结局指标
主要结局
Gingival Recession Depth (GRD)
时间窗: 6 months
Measuring gingival recession depth (GRD) using UNC Periodontal probe in millimeter (mm)
次要结局
- The Distance between the contact point and the top of the papilla (DCP)(6 months)
- Gingival Recession Width (RW)(6 months)
- Probing Pocket Depth (PPD)(6 months)
- Clinical Attachment Level (CAL)(6 months)
- Gingival Index (GI)(6 months)
- Plaque Index (PI)(6 months)
- Keratinized Tissue Width (KTW)(6 months)
- Root Coverage Esthetic Score (RES)(6 months)
- The Distance between the contact point and the top of the papilla (DCP)(6 months)
- Probing Pocket Depth (PPD)(6 months)
- The Percentage of Mean Root Coverage (MRC %)(6 months)
- Complete Root Coverage (CRC)(6 months)
- Gingival Recession Width (RW)(6 months)
- Clinical Attachment Level (CAL)(6 months)
- Gingival Index (GI)(6 months)
- Keratinized Tissue Width (KTW)(6 months)
- Plaque Index (PI)(6 months)
- Gingival Thickness (GT)(6 months)
- Postoperative Patient Satisfaction (Visual Analogue Scale)(6 months)
研究者
Khaled Hashem Kamal
Bachelor Degree
Cairo University
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