Clinical Evaluation of a Modified Technique for Free Gingival Graft Stabilization Using Titanium Fixation Tacs Around Implants Versus Conventional Suturing Technique: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Width of keratinized gingiva
研究概览
简要总结
The aim of this randomized, controlled, parallel-grouped, clinical trial is to evaluate the width of keratinized gingiva after free gingival graft stabilized by titanium fixation tacs compared to traditional suturing.
Research question:
In patients with inadequate keratinized gingiva undergoing soft tissue augmentation by free gingival graft , will graft stabilization using Titanium fixation tacs affect the amount of keratinized tissue gain compared to graft stabilization using sutures ?
详细描述
Free gingival graft obtained from the palate, usually replaces missing or lost keratinized tissue. Although it represents the gold standard, its success relies on providing intimate and atraumatic stabilization, as maintaining the plasmatic circulation is crucial for graft healing and perfusion, considering that judging the success of free gingival graftis based on the extent of the postoperative healing contraction and the quality of graft adherence to the underlying periosteum.
Suturing can be time consuming and sometimes fail to achieve a positive result. Also it was reported that for every one-minute increase of the gingival augmentation procedure time, there is a 4% likely increase for pain and a 3% for swelling.
However, by using fixation tacs the surgical time can be significantly reduced and the procedure can be less technique sensitive.
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, Investigator)
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
- •Systemically healthy individuals of age ≥ 18 to 40 years with absence of active periodontal disease.
- •Having inadequate width of keratinized gingiva (< 2 mm).
- •No systemic disease according to Modified Cornell Medical Index health questionnaire
- •Non-smoker.
- •Full mouth plaque index (PI) and full-mouth bleeding on probing (BOP) score of ≤ 15%.
- •No malocclusion, crowding, fillings, missing or supernumerary mandibular anterior teeth.
- •No blood-borne conditions.
排除标准
- •Active orthodontic treatment.
- •Previous periodontal surgery.
- •Systemic disease.
- •Use of blood thinners.
- •Use of any drugs that might lead to gingival enlargement.
- •Mucogingival stress, bruxism.
- •Pregnancy or lactation.
结局指标
主要结局
Width of keratinized gingiva
时间窗: 6-month
次要结局
- Surgery time(Perioperative)
研究者
Mohamed Atef Kamal Ibrahim
Principal Investigator
Cairo University