Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Recession depth
研究概览
简要总结
Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000).
Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage.
The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini & Pini Prato 2012).
The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 60 years.
- •Periodontally and systemically healthy.
- •Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth.
- •Full-mouth plaque and bleeding score of <15% and no probing depths >3 mm.
- •Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites.
排除标准
- •RT3 recession defects.
- •Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
- •Presence of caries lesions or restorations in the cervical area.
- •Intake of medications which impede periodontal tissue health and healing.
- •Medical contraindications for periodontal surgical procedures.
- •Uncooperative patients not willing to complete the follow up period.
- •Pregnancy and lactation.
结局指标
主要结局
Recession depth
时间窗: 3-6 month
Measured from the CEJ to the most apical extension of the gingival margin.
次要结局
- Keratinized tissue width(3-6 months)
- Post-Surgical Patient Satisfaction(1 week)
- Post-Operative Pain(1 week)
- Surgical time(intraoperative)
- Recession width(3-6 month)
- Percentage of root coverage(6 months)
- Root coverage esthetic score(6 months)
- Gingival Thickness(3-6 months)
研究者
Mohamed Mashaly
Assistant lecturer of Periodontology
Cairo University