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临床试验/NCT03200392
NCT03200392已完成不适用

The Use Of Er,Cr:YSGG Laser For Recipient Bed Bio-modification And De-epithelialized Palatal Graft Harvesting In The Treatment of Gingival Recession Defects -(Randomized Clinical Trial)

Misr International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Change in Recession depth

研究概览

简要总结

A clinical and radiographic evaluation of using Erbium, Chromium, Scandium, Gallium and Garnet (Er,Cr:YSGG) laser in recipient site bio-modification and de-epithelialized connective tissue graft harvesting compared to conventional scalpel surgical technique in the treatment of class I and II Miller gingival recession.

详细描述

Twenty four patients suffering from isolated Class I and II Miller gingival recession defects in anterior esthetic region were enrolled in this study. They were randomly assigned into three groups; de-epithelialized connective tissue graft harvesting technique or; conditioning the exposed root surfaces with Er,Cr:YSGG laser before connective tissue coverage using scalpel blade harvested de-epithelialized connective tissue graft harvesting technique, or; conditioning the exposed root surfaces with the Er,Cr:YSGG laser before Er,Cr:YSGG laser harvested connective tissue using de-epithelialized technique. Clinical and radiographic parameters were recorded at baseline and at 3, 6 and 9 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)

盲法说明

Masking of investigator and participants was not applicable due to surgical procedure and use of laser either for root surface bio-modification or during connective tissue harvesting. The blinded outcome assessor performed the clinical measurements at each selected defect site during the study period. She was not involved in any other part of the study protocol.

入排标准

年龄范围
21 Years 至 58 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Single class I, II Miller gingival recession defects (≥ 2mm in depth), presence of identifiable buccal cemento-enamel junction (CEJ) and presence of a step ≤ 1 mm at CEJ.
  • Controlled periodontal disease
  • Full-mouth plaque score of <10%; full-mouth gingival score of <15%
  • Patients available for 9 months follow-up period.

排除标准

  • Pregnant and lactating females.
  • Taking medications known to interfere with periodontal tissue health or healing.
  • Previous periodontal surgery on the involved sites.
  • Non-vital teeth.
  • Molar teeth.
  • Recession defects associated with caries or restoration.
  • Occlusal interferences.
  • Taking anti-inflammatory drugs or antibiotics in the past 6 months.

结局指标

主要结局

Change in Recession depth

时间窗: baseline-3-6-9 months

measured from the gingival margin to the cemento-enamel junction at the mid-buccal aspect of the tooth using William's graduated periodontal probe to the nearest mm

次要结局

  • Height of keratinized tissue width(baseline and at 9 months)
  • Pain assessment at the donor site(7 days)
  • number of analgesic pills consumed per day(7 days)
  • Recession width(baseline-3-6-9 months)
  • Gingival thickness(baseline and at 9 months)
  • Clinical attachment loss(baseline-3-6-9 months)
  • Probing pocket depth(baseline-3-6-9 months)

研究者

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

Tarek Mahmoud Nasser Eltayeb

laser certified from Aachen University (Germany) and Assistant Lecturer of Periodontology, Oral Medicine and Oral Diagnosis

Misr International University

研究点 (2)

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