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临床试验/NCT02441127
NCT02441127已完成不适用

Diode Laser For Harvesting Subepithelial Connective Tissue Graft in The Treatment of Gingival Recession Defects: A Novel Approach to Limit Morbidity

Cukurova University2 个研究点 分布在 2 个国家目标入组 52 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Oral health related quality of life

研究概览

简要总结

Aims: The aim of present randomized controlled clinical study was to evaluate whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the coronally advanced flap (CAF) with connective tissue (CTG) grafts.

Methods: Fifty-two patients with isolated recessions were treated. The CTG resulted from the de-epithelialization of a free gingival graft (FGG) with blade (control group) or diode laser (DL) (test group). The DL was used to de-epithelialize the outer part of the FGG and photo-biostimulate the palatal wound area. Post-operative morbidity was evaluated by using Oral health related Quality of life (QoL), smile related QoL and visual analogue scale-discomfort (VAS). Root coverage outcomes were also evaluated 6 months after operation.

详细描述

The procedure of connective tissue harvesting from the palate is often characterized by the challenge of obtaining the largest volume of tissue possible on one side while minimizing post-operative pain and reducing the risk of complications on the other.The present clinical study evaluated whether the additional use of diode laser would facilitate the donor surgery, improve the palatal wound healing and reduce post-operative morbidity after the bilaminar periodontal plastic surgery procedure for the treatment of isolated single gingival recession defects with no loss of interdental clinical attachment.

In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode. In the control group,a free (epithelialized) gingival graft was harvested by two horizontal and two vertical incisions defining the area. The post operative course of the patients were evaluated by visual analogical scale and the oral health impact profile

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 (Participant)

入排标准

年龄范围
21 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of identifiable buccal cemento-enamel junction;
  • Presence of a step ≤ 1mm at the cemento-enamel junction level
  • No contraindications for periodontal surgery and no periodontal surgery on the involved sites
  • Full-mouth plaque score of <10%; full-mouth bleeding score of <15%
  • No occlusal interferences.

排除标准

  • History of periodontitis or abscess formation
  • Presence of systemic disease
  • Pregnant patients.

研究组 & 干预措施

Diode laser group

Experimental

In the test sites, an aluminum, gallium, and arsenide diode laser (wavelength 810 nm and power of 1W) was applied in continuous mode.

干预措施: diode laser group (Device)

Scalpel control group

Active Comparator

The surgical technique used in the control group was a FGG harvested by two horizontal and two vertical incisions by scalpel defining the area to be harvested .

干预措施: scalpel control group (Procedure)

结局指标

主要结局

Oral health related quality of life

时间窗: 6 months

次要结局

  • Post-operative Discomfort on the Visual Analog scale(1 month)
  • Smile related quality of life(6 months)
  • Complete root coverage(6 months)

研究者

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

Onur Ozcelik

Professor

Cukurova University

研究点 (2)

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