Growth Factor Enhanced Matrix Combined Either With Free Connective Tissue Graft or With Collagen Membrane in the Treatment of Miller Class II Gingival Recession
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Gingival thickness (Gingival biotype)
研究概览
简要总结
The study aimed to compare, the effectiveness of Growth Factor Enhanced Matrix (GEM 21s) ® combined either with free connective tissue graft or collagen membrane in the treatment of Miller class II gingival recession.
详细描述
Materials and Methods
Twenty sites in 10 patients, with class II Miller gingival recession were allocated randomly to be treated by (GEM 21s) ® with free connective tissue graft (groupI) or GEM 21s with collagen membrane (groupII). Plaque index, bleeding on probing, recession width, recession depth, height of keratinized tissue and digital measurements were recorded at baseline, 1, 3 and 6-months'. Probing pocket depth, clinical attachment level, gingival thickness and Radiographic parameters were recorded at baseline and 6 months'. Root coverage percentage were recorded 6 months postoperative and wound healing index were recorded at 1,3 and 6-months' post-operative .
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lack of any related medical issues that contraindicate periodontal surgery,
- •optimum adherence as confirmed by a positive attitude towards oral hygiene, and successfully showing up for treatment appointments.
- •No history of any medications in the previous six months that may interfere with periodontal surgery Gingival thickness for the selected sites should be > 1mm (as measured 2mm apical to gingival margin),
- •Clinical attachment level ≥ 4mm measured from cemento-enamel junction till the deepest probing depth.
排除标准
- •the presence of class V caries or restoration in the site to be treated,
- •previous mucogingival surgery at the selected site.
- •Teeth that are tilted, rotated, or have any occlusal abnormalities.
- •Smokers and pregnant patients were excluded from the participation.
结局指标
主要结局
Gingival thickness (Gingival biotype)
时间窗: up to 6 months
measured at mid-buccal area 2 mm apical to the free gingival margin measured at baseline, and 6 months postoperatively
Recession width
时间窗: up to 6 months
the distance between the mesial and distal papillae along the CEJ measured at baseline , 1, 3, and 6 months
radiographic measurements of facial bone level, thickness and density
时间窗: up to 6 months
from cone beam CT radiography measured at baseline, and 6 months postoperative
Percentage of root coverage
时间窗: up to 6 months
according to the following formula: (RD at baseline - RD at 6 months) / RD at baseline)x100 was calculated after 6 months
recession depth
时间窗: up to 6 months
The distance between the CEJ and the gingival margin at the midbuccal aspect of the involved tooth measured at baseline , 1, 3, and 6 months
Height of keratinized tissue
时间窗: up to 6 months
distance from the most apical point of the free gingival margin to the mucogingival junction mid-facially measured at baseline , 1, 3, and 6 months
次要结局
- probing pocket depth(up to 6 months)
- healing index(up to 6 months)
- Digital measurements(up to 6 months)
- clinical attachment level(up to 6 months)
研究者
malak mohamed shoukheba
professor of oral medicine, oral periodontology, oral diagnosis and diagnosis
Tanta University