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临床试验/NCT02626117
NCT02626117Unknown4 期

Laser De-epithelialization for Epithelial Exclusion in Root Coverage Procedure: a Clinical Study

Krishnadevaraya College of Dental Sciences & Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
20
试验地点
2
主要终点
Percentage of root coverage (PRC)

研究概览

简要总结

The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

详细描述

Successful treatment of recession defects to obtain new attachment and prevent repair by long junctional epithelium continues to present a serious therapeutic challenge. The concept of laser deepithelialization to retard epithelial migration has enabled new attachment formation in periodontal pockets. Based on this hypothesis, that laser deepithelialization during root coverage procedures will enhance clinical outcome, a split mouth randomized controlled clinical trial was planned to compare the clinical outcome of Coronally advanced flap (CAF) + subepithelial connective tissue graft (SCTG) alone and in combination with laser de-epithelialization in the treatment of gingival recession.

METHOD:

In a split-mouth study, 20 patients presenting at least one pair of bilaterally symmetrical Miller's Class I and Class II buccal gingival recessions will be selected. Control site will receive coronally advanced flap with connective tissue graft and test site will receive laser deepithelialization as an adjunct to coronally advanced flap with connective tissue graft. Gingival recession depth (GRD), Gingival recession width (GRW), Probing depth (PD), Clinical attachment level (CAL), Keratinized tissue width (KTW), Plaque index (PI), Gingival index (GI), Gingival bleeding index (GBI) will be measured at baseline, 6 weeks, 3 months and 6 months after treatment. The root coverage outcomes were also assessed by photogrammetric analysis.

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 57 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Miller's Class I and II recession defects involving maxillary or mandibular canines or premolars.
  • Similar bilateral recession defects.
  • Systemically healthy patients.
  • Patients willing to participate in study.
  • Age group of 21-57 years.
  • Patients with esthetic concerns.

排除标准

  • Pregnant and lactating woman
  • Patients who have undergone any type of regenerative periodontal therapy six months prior to the initial examination.
  • Patients with history of smoking.
  • Teeth with hopeless prognosis.
  • Root surface restoration.

结局指标

主要结局

Percentage of root coverage (PRC)

时间窗: 6 months

Complete root coverage

时间窗: 6 months

次要结局

  • Reductions in recession depth (Rec Red)(6 months)
  • Gingival recession width (GRW)(6 months)
  • Probing depth (PD)(6 months)
  • Clinical attachment level (CAL)(6 months)
  • Keratinized tissue width (KTW)(6 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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