Clinical Evaluation of Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- recession depth
研究概览
简要总结
The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).
详细描述
The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.
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
- 20 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between 18 - 60 years old.
- •Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
- •Subjects able to tolerate surgical periodontal procedures.
- •Accepts the 6 months follow-up period.
排除标准
- •Current and former smokers.
- •Pregnant females.
- •Subjects received any periodontal therapy for a minimum of 6 months prior to the study.
- •Subjects taking drugs known to interfere with wound healing.
- •Subjects with unacceptable oral hygiene with plaque index >
- •Teeth with non-carious cervical lesions, cervical caries and malalignment.
结局指标
主要结局
recession depth
时间窗: Change in mm from baseline before surgical procedure to follow up at 6 months.
It is measured as the distance from the cemento-enamel junction to the gingival margin representing the amount of root coverage.
次要结局
- Recession Width(Change in mm from baseline before surgical procedure to follow up at 6 months.)
- Width of keratinized gingiva(Change in mm from baseline before surgical procedure to follow up at 6 months.)
- Patient reported outcomes(taken after completion of the study at 6 months)
- Clinical attachment level(Change in mm from baseline before surgical procedure to follow up at 6 months.)
- Probing pocket depth(Change in mm from baseline before surgical procedure to follow up at 6 months.)
- Tissue Biotype(Change in mm from baseline before surgical procedure to follow up at 6 months.)
- root coverage esthetic score(score taken after completion of the study at 6 months)
研究者
Noha Ayman Ghallab
Associate Professor of Oral Medicine and Periodontology
Cairo University