Evaluation The Efficacy of Vestibular Incision Subperiosteal Tunnel Access With Fascia Lata Allograft in The Treatment of Gingival Recession A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- change in Gingival recession depth
研究概览
简要总结
The present study will be conducted as a randomized controlled clinical study to assess to evaluate the effect of minimally invasive VISTA with fascia lata allograft in the treatment of gingival recession
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of gingival recession type 1 (RT1) Cairo classification (6)
- •Gingival recession depth ≥ 2 mm.
- •Gingival thickness for the site selected should be ≥1mm.
- •The height of keratinized gingiva (HKG) for the site selected should be ≥2 mm (HKG is the distance between the most apical point of the gingival margin and the mucogingival junction).
- •Optimal compliance as evidenced by no missed treatment appointments and a positive attitude toward oral hygiene.
排除标准
- •Presence of any systemic disease that could influence the outcome of the therapy.
- •Presence of any risk factor e.g.; smoker, pregnant and lactating patients.
- •Previous history of periodontal surgical treatment in quadrant selected for the study.
- •Restorations or caries in the area to be treated and non-vital tooth.
- •Teeth which are tilted or rotated.
- •Patients taking medications known to cause gingival enlargement.
研究组 & 干预措施
Test Group
干预措施: Vestibular incision sub-periosteal tunnel access + fascia lata (Other)
Control Group
干预措施: Vestibular incision sub-periosteal tunnel access + subepithelial connective tissue graft (Other)
结局指标
主要结局
change in Gingival recession depth
时间窗: 2 weeks, 3 months, 6 months
will be measured at the mid-buccal aspect of the tooth from the (CEJ) to the most apical point of the gingival margin (GM).
change in Gingival recession width (GRW)
时间窗: 2 weeks, 3 months, 6 months
it will be measured at the mesiodistal direction of the GM at the level of CEJ
次要结局
- change in Keratinized tissue width (KTW)(2 weeks, 3 months, 6 months)
- change in Clinical attachment loss (CAL)(2 weeks, 3 months, 6 months)
- change in Probing depth (PD)(2 weeks, 3 months, 6 months)
- change in Gingival thickness (GT)(2 weeks, 3 months, 6 months)
- change in Recession esthetic score (RES)(2 weeks, 3 months, 6 months)
- change in Percentage of root coverage (RC)(2 weeks, 3 months, 6 months)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University