Efficacy of a Modified Technique of Free Gingival Graft in Volumetric Changes of the Graft: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Apical-cervical width of keratinized tissue after 12 months
研究概览
简要总结
This study will compare a new technique of free gingival graft to the original one, in order to evaluate the stability of the graft volume over one year and other variables. Twenty patients will receive the original technique of free gingival graft (controls) and twenty patients will receive the modified technique, in which the free gingival graft is submerged (tests), at the inferior incisors area.
详细描述
The free gingival graft surgery is held to gain some keratinized tissue in areas where it has been lost, such as in inferior incisors with gingival recessions. In these areas, tooth brushing may become harder and painful, negatively influencing in plaque control. However, this type of graft seems to contract over time. A new approach of free gingival graft, in which the graft is covered by a flap, promises to provide greater vascularization. This would promote less graft contraction and better mucosal color. Forty patients with less than 2 mm of keratinized tissue (measured from gingival margin to mucogingival junction) in at least one inferior incisor will be included. Half will receive the original technique and half will receive the modified one. Patients will be followed at 7, 14, 21, 28, 42 days, 3, 6, 12 months and 8 years after surgeries.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reduced keratinized tissue (less than 2 mm) in inferior incisors area
- •Healthy periodontium in inferior incisors area
- •Indication for surgery (e.g. pain during tooth brushing, gingival margin mobility, gingival recession...)
- •Recessions class I, II or III, maximum 3 mm
- •Having signed the informed consent
排除标准
- •Systemic diseases
- •Pregnant and lactating women
- •Root caries lesions
- •Previous surgeries at same area
- •Accentuated root abrasion
- •Malpositioning teeth
- •Residual pocket depths greater than 4 mm
- •Tooth mobility greater than 1
研究组 & 干预措施
Modified Free Gingival Graft
Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery.
干预措施: Free Gingival Graft (Procedure)
Modified Free Gingival Graft
Twenty patients will receive the modified free gingival graft technique at the inferior incisors area. In this technique, the graft is covered by a flap, similarly to what is done in a connective tissue graft surgery.
干预措施: Modified Free Gingival Graft technique (Procedure)
Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
干预措施: Free Gingival Graft (Procedure)
Original Free Gingival Graft technique
Twenty patients will receive the original technique of free gingival graft at the inferior incisors area.
干预措施: Original Free Gingival Graft technique (Procedure)
结局指标
主要结局
Apical-cervical width of keratinized tissue after 12 months
时间窗: 12 months
Distance between gingival margin and mucogingival junction, in millimeters
次要结局
- Postoperative discomfort(28 days)
- Probing Depth(12 months)
- Keratinized tissue area(12 months)
- Keratinized tissue thickness(12 months)
- Volume of receiving area(12 months)
- Complete epithelization of donor area(28 days)
- Oral Health Related Quality of Life (OHIP)(12 months)
- Clinical Attachment Level(12 months)
- Recession(12 months)
- Gum color(12 months)
- Bleeding on probing(12 months)
研究者
Claudio Mendes Pannuti
Associate Professor
University of Sao Paulo