NCT06615687尚未招募不适用
Inverted T-shape Free Gingival Graft Versus Free Gingival Graft for Treatment of RT2/RT3 Gingival Recession Defects : 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
- 34
- 试验地点
- 1
- 主要终点
- Recession depth.
研究概览
简要总结
The aim of this study is to compare the use of T-inverted shape Free Gingival Graft with Free Gingival Graft for improving the clinical attachment, gain partial root coverage, and improve Keratinized tissue width in recession type 2 /recession type 3 gingival recession defects .
Research question : In patients with RT2 / RT3 mandibular defects will the use of inverted T-shape free gingival graft differ from free gingival graft in Recession depth?
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with RT2/RT3 gingival recession.
- •Indication for FGG treatment at mandibular incisor area (i.e., difficulty or discomfort during oral hygiene; gingival margin mobility; high muscle attachment and/or frenum pull; shallow vestibule and gingival recession.
- •KT width (KTW) < 2 mm.
- •Ages 18-40 years old.
- •Patients with healthy systemic condition (Brightman. 1994).
- •Gingival and plaque index <
- •Good oral hygiene (Wiesner et al. 2010).
- •Accepts 6 months follow-up period (cooperative patients)
排除标准
- •Poor oral hygiene.
- •Patient with a physical disability that hinders the upkeep of good oral hygiene measures.
- •Intake of any medications known to affect gingival homeostasis or to interfere with wound healing.
- •Pregnant or lactating women.
- •RT1 gingival recession.
- •Caries or non-carious cervical lesions at recipient sites.
- •Severely malpositioned teeth.
- •Teeth with residual probing depth ≥ 4 mm.
- •Mobility ≥ 1 mm.
- •Pervious periodontal surgery within the last 6 months before the start of the trial.
- •Patients with active periodontal disease. -
研究组 & 干预措施
Inverted T -Shape Free Gingival Graft
Experimental
干预措施: Inverted T shape Free Gingival Graft (Procedure)
Free Gingival Graft
Active Comparator
干预措施: Free Gingival Graft (Procedure)
结局指标
主要结局
Recession depth.
时间窗: baseline, 1 month , 3 months and 6 months
Will be measured as the distance from the CEJ to the most apical extension of the gingival margin.
次要结局
- Width of keratinized gingiva .(baseline, 1 month , 3 months and 6 months)
- Recession width(baseline, 1 month , 3 months and 6 months)
- Gingival thickness(baseline, 1 month , 3 months and 6 months)
- Root coverage esthetic score(baseline, 1 month , 3 months and 6 months)
- The Distance between the contact point and the top of the papilla (DCP).(baseline, 1 month , 3 months and 6 months)
- Probing Depth(baseline, 1 month , 3 months and 6 months)
- Gingival Index(baseline, 1 month , 3 months and 6 months)
- Plaque Index(baseline, 1 month , 3 months and 6 months)
研究者
Dina Galal Fouad Mohamed Hafeez
Principal investigator
Cairo University
研究点 (1)
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