Gingival Augmentation and Root Coverage Results With Superficial and Deep Cut Acellular Dermal Matrices
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Keratinized tissue width
研究概览
简要总结
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing root coverage for gingival recession will be enrolled.
详细描述
Each subject will be randomized to one of the treatments for the first side and the contralateral side will receive the other treatment. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups, a commercially available allograft (ADM-D or ADM-S) will be used.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
Grafting teeth with gingival recession is often done to improve esthetics and tooth sensitivity as well as prevent recession from progressing. When recession coverage procedures are done, a soft tissue graft material is inserted between the gums and the tooth to help decrease the amount of root exposure. This material is obtained from a donor and may originate from a deeper or shallower layer of the donor skin. The study team seek to determine if the origin of the graft material (deep or shallow) influences the amount of root coverage achieved.
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between age 18 and 89
- •Patients needing root coverage procedures for gingival recession in one or more teeth in the same arch bilaterally (split mouth)
- •Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report.
- •Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
排除标准
- •Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- •Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- •Pregnant women or women intending to become pregnant during study period.
- •Smokers who smoke > 10 cigarettes per day
研究组 & 干预措施
Control Group: Acellular Dermal Matrix - Superficial cut (ADM-S)
A commonly used allograft material is the Acellular Dermal Matrix (ADM) which is harvested from human donor dermal tissues. Most commercially available ADM products are superficial cuts.
干预措施: Allograft Material ADM-S (Other)
Test Group:Acellular Dermal Matrix - Deep cut (ADM-D)
The use of a deep cut ADM for root coverage gingival plastic procedures.
干预措施: Allograft Material ADM-D (Other)
结局指标
主要结局
Keratinized tissue width
时间窗: Baseline to 12 months
Measured as change in keratinized tissue width
Percentage root coverage
时间窗: Baseline to 12 months
Measured as change in percentage root coverage
次要结局
未报告次要终点
研究者
Angela Palaiologou-Gallis, DDS, MS
Professor and Program Director, Graduate Periodontics
The University of Texas Health Science Center at San Antonio