Effect of Botulinum Toxin -A Injection in Mentalis Muscle with Coronally Advanced Flap and De-epithelized Free Gingival Graft in Treatment of RT1 , RT2 Gingival Recession _Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- Keratinized tissue width
研究概览
简要总结
The goal of this study type: clinical trial] is to learn the effect of Botulinum Toxin _A injection in treatment of RT1andRT2 Gingival recession in lower anterior teeth .
Primary outcome is keratinzed tissue width. Researchers will compare Coronally Advanced flap with De-epithelized free gingival graft and Botulinum toxin-A injection in Mentalis muscle with coronally advanced flap with De-epithelized free gingival graft alone .
The outcome will be measured at baseline, after 3 months and after 6 mobths _medical history
- 3 mm horizontal incisions, then two vertical incisions
- deepitheliztion of anatomical papillae
- superficial and deep incisions
- harvesting DFGG
- Suturing
- BOTOX injection
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 (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
- •Single or multiple RT1, RT2 GR patient
- •patients ≥18 years
- •systemically healthy, full mouth plaque score, full mouth bleeding score ≤ 15% after phase I therapy
- •clinical indication and/or patient request for recession coverage
- •well motivated patients, maintaining oral hygiene throughout study
排除标准
- •Pregnant or lactating women
- •Smokers' patients
- •Teeth with cervical restorations/abrasion.
- •Patients had a systemic condition affect blood components and healing
研究组 & 干预措施
Intervention arm
In this arm principal investigator will preform coronally advanced flap with De-epithelized free gingival graft then will inject Botulinum toxin-A in Mentalis muscle after suturing
干预措施: Botulinum toxin-A injection (Procedure)
Control arm
In this arm no injection will be applied only coronally advanced flap with De-epithelized free gingival graft alone
干预措施: Coronally advanced flap (Procedure)
结局指标
主要结局
Keratinized tissue width
时间窗: Measured at baseline ,3months ,6 months
次要结局
未报告次要终点
研究者
Mayar Mostafa Tawfik Ali
Principal investigator
Cairo University