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临床试验/NCT03582995
NCT03582995已完成不适用

Root Coverage With Acellular Dermal Matrix and Bovine Derived Osseous Xenograft Using Either a Coronally Positioned Tunnel or Coronally Positioned Flap

University of Louisville2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Percentage of root coverage

研究概览

简要总结

The study will consist of a randomized controlled clinical study trial comparing the results of coronally positioned flap with AlloDerm GBR plus bovine derived xenograft versus coronally positioned tunnel with AlloDerm GBR plus bovine derived xenograft in approximately 30 patients (15 per group). All materials used in the study are FDA approved.

详细描述

Patients will be assigned to one of two treatment groups. In the positive control group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle (Dodge et. al, 1998). The coronally positioned flap will be sutured separately and coronally positioned using a continuous sling suture technique (papilla to papilla sutures) with a Maxon 5-0, 3/8 circle 13 mm needle. In the test group, BX will be placed over the root and bone surface of the defect, covered with ADM GBR® and sutured together using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle. The coronally positioned tunnel will be sutured together and coronally positioned using a continuous sling suture technique (line angle to line angle) with a Maxon 5-0, 3/8 circle 13 mm needle.

Post-operative instructions will be given to the patients along with prescriptions, in appropriate cases, for systemic doxycycline 100 mg once a day for 14 days; an anti-inflammatory agent (naproxen 375 mg q12h for 7 days); an analgesic (hydrocodone/acetaminophen 5/325mg q6-8h prn pain); a steroid, Medrol dose pack, 21 tablets of 4 mg methylprednisolone; 6 tablets on day 1, 5 on day 2, decrease by 1/day until last tablet dose on day 6, or dexamethazone 1mg, 18 tablets, 3 tablets/day for 1st3 days, 2/day for the next 3 days, 1/day for the last 3 days (always taken in the morning).

All patients will be seen at week 1 or 2, 4, 8, 16 and 24, at which time the final exam will be completed. Sutures will be removed between weeks 4-8, as indicated. Post-operative visits will consist of supragingival plaque removal and oral hygiene reinforcement. Any patient who develops any adverse reaction to the materials used or shows attachment loss ≥2.0 mm will be exited from the study and will receive the appropriate treatment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A. At least one Miller Class I or II mucogingival defect ≥ 3 mm (Miller 1985).
  • B. The mucogingival defect must be on a non-molar tooth.
  • C. Patients must be ≥ 18 years of age.

排除标准

  • A. Patients with debilitating systemic or diseases that significantly affect the periodontium.
  • B. Patients with a known allergy to any of the materials that will be used in the study, including systemic antibiotics (tetracycline and doxycycline).
  • C. Patients requiring antibiotic prophylaxis.
  • D. Root surface restorations at the site of recession.
  • E. No detectable CEJ
  • F. Patients who fail to maintain oral hygiene levels of at least 80% plaque free surfaces.
  • G. Patients who are pregnant or lactating.
  • H. Patients who use tobacco products (smoking or smokeless tobacco).
  • I. Patients with alcohol abuse problems.
  • J. Patients undergoing long-term steroid therapy.
  • K. History of previous root coverage procedures, graft or GTR, on the test teeth.
  • L. Patients who fail to complete the informed consent form

结局指标

主要结局

Percentage of 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

  • Tissue thickness(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry Greenwell

Program Director

University of Louisville

研究点 (2)

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