Root Coverage With Acellular Dermal Matrix Using the Coronally Positioned Tunnel Technique Comparing Two Different Donor Materials
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percent root coverage
研究概览
简要总结
Root coverage with acellular dermal matrix using the coronally positioned tunnel technique comparing two different donor materials
详细描述
Thirty patients will be treated: 15 with a coronally positioned tunnel technique with NovaDerm® xenograft using continuous sling suture to secure both the graft and the flap (test treatment) and 15 with a coronally positioned tunnel technique with AlloDerm® allograft using continuous sling suture to secure both the graft and the flap (control treatment). Sutures used for the control group will be Maxon 5-0, 3/8 circle 13 mm needle for both the test and control groups. The coronally positioned tunnel technique was previously described by Edwards Pat Allen (E.P. Allen, Center for Advanced Dental Education, Dallas, Texas; course manual). Each patient will provide at least one Miller Class I or II facial recession defect, ≥ 3 mm. Patients will be randomly selected by a coin toss to receive either the test or control treatment. Mentor will toss the coin immediately prior to suturing. Patients will be evaluated postoperatively for a period of 4 months. The examiner will be blinded and will not be aware of the patient treatment at any time during the term of the study. Three exams for measurements will be performed per patient on total: preoperative, at week eight and 16 (4 months) postoperatively.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
- •The mucogingival defect must be on a non-molar tooth.
- •Patients must be at least 18 years of age.
排除标准
- •Patients with debilitating systemic or diseases that significantly affect the periodontium.
- •Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
- •Patients requiring antibiotic prophylaxis.
- •Root surface restorations at the site of recession.
- •No detectable CEJ
- •Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
- •Patients who are pregnant or lactating.
- •Patients who use tobacco products (smoking or smokeless tobacco).
- •Patients with alcohol abuse problems.
- •Patients undergoing long-term steroid therapy.
- •History of previous root coverage procedures, graft or GTR, on the test teeth.
- •Patients who fail to complete the informed consent form.
研究组 & 干预措施
Tunnel + AlloDerm®
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).
干预措施: Tunnel + AlloDerm (Procedure)
Tunnel + Novomatrix
A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).
干预措施: Tunnel + Novomatrix (Procedure)
结局指标
主要结局
Percent root coverage
时间窗: 4 months
Initial and final recession will be measured from the cementoenamel junction to the gingival margin in millimeters. Root coverage will be determined by the amount of initial recession minus the final recession. Percent root coverage will be determined by root coverage divided by initial recession, multiplied by 100.
次要结局
未报告次要终点
研究者
Henry Greenwell
Professor, Director Graduate Periodontics
University of Louisville