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临床试验/CTRI/2024/05/066699
CTRI/2024/05/066699尚未招募不适用

Effects of Er:YAG laser vs Surgical De-Epithelization of Free Gingival Grafts on Dimensional Changes and Esthetics-A Three Arm Controlled Clinical Trial.

Dr Rayapati lois sowmya Abhinandhitha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Color match

研究概览

简要总结

The aim of the study is to evaluate and compare the effect of Er:YAG LASER vs Surgical de-epithelization of free gingival grafts on Dimensional changes and colour match after gingival augmentation.

A total of 30 Patients visiting Vishnu Dental college with miller’s class I/II/III gingival recessions will be recruited. A written informed consent will be obtained from all the patients and they will be divided into three groups, Control and two test group. In the control group,free gingival graft will be performed in patients with miller’s class I/II/III recession. In the Test group 1 surgical de-epithelization of free gingival graft will be performed in patients with miller’s class I/II/III recession.In test group 2 de-epithelization will be performed with Er:yag laser in patients with miller’s class I/II/III recession. After the treatment Graft Width(GW),Graft length(GL),Graft thickness(GT),Graft dimension/Graft Area(GD) assessment will be done at baseline, 1 month, 3 months and at 6 months. Color match with 21 Numeric Rating Scale- will be assessed at 3 months and 6 months.Healing Index (landry healing index) at 1 week and 1 month. Degree of De-epithelization with toluidine blue will be assessed at baseline and 1 week. After the treatment patient will be asked to return to the study center at baseline,1 week,1 month,3 months and 6 months for dimensional changes,colour match and healing index. the data will be analysed individually for all the patients .there is no conflict of interest.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Day(s) 至 50.00 Day(s)(—)
性别
All

入选标准

  • Patients with periodontal health in a reduced periodontium Non periodontitis/ stable periodontal health (2017 Classification) with Miller’s class I, II & III gingival Reccesion, Attached gingiva less than 1mm will be selected
  • Age-25 to 50 years
  • Presence of Miller’s class I / II /III gingival recession in maxillary/mandibular anteriors
  • Full mouth plaque score (FMPS) of less than 20%.
  • (O’leary plaque index,1972)
  • Full mouth gingival bleeing score(FMBS) of less than 20%.
  • Attached gingiva less than 1mm.

排除标准

  • Patients with uncontrolled systemic diseases
  • Autoimmune,Infectious,Inflammatory conditions, or Intake of anticoagulants
  • Pregnancy or lactating women
  • Presence of mobility.

结局指标

主要结局

Color match

时间窗: 3 months and 6 months

Graft thickness

时间窗: 3 months and 6 months

Graft length

时间窗: 3 months and 6 months

Graft width

时间窗: 3 months and 6 months

Graft area

时间窗: 3 months and 6 months

次要结局

  • Healing index(Degree of de-epithelization)

研究者

发起方
Dr Rayapati lois sowmya Abhinandhitha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Rayapati lois sowmya Abhinandhitha

vishnu dental college

研究点 (1)

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