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临床试验/CTRI/2024/05/067185
CTRI/2024/05/067185尚未招募3 期

Comparative Evaluation Of Effectiveness Of Hyaluronic Acid Gel And Vitamin E Application On Healing After Laser Gingival Depigmentation– A Randomized Clinical Trial

Dr Samiksha Mandavkar1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Hyaluronic acid gel application versus Vitamin E application after laser gingival depigmentation have any beneficial effect on

研究概览

简要总结

This is a randomised, single blinded study. In today’s era, facial cosmetic concerns as well as increase intraoral awareness have created a demand for aesthetics in periodontal practice. Clinical melanin pigmentation is benign and is not a medical problem, but pigmented gingiva may be a cause of aesthetic concern particularly in patients with high smile line or gummy smile. Laser ablation has been recognised recently as the most effective, pleasant, and reliable technique. It has advantage of easy handling, short treatment time, haemostasis, decontamination, and sterilization effect. However,  till date no study has been conducted where in healing effects of HA is compared with Vitamin E after laser gingival depigmentation. Hence, the present study will be undertaken. 

In this study, a total of 24 individuals with 48 sites having gingival hyperpigmentation will be recruited. The sites will be divided by simple randomization technique as,Site A- Site will be treated with HA and Site B- Site will be treated with Vitamin E.Patients will be recalled after 1week, 2week, 4week and 3months post-operatively and all the parameters will be evaluated.

研究设计

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

入排标准

年龄范围
15.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy cooperative subjects Age group of 15-45 years of either sex Presence of bilateral gingival melanin hyperpigmentation (DOPI Index score 2 or greater than 2).

排除标准

  • 未提供

结局指标

主要结局

Hyaluronic acid gel application versus Vitamin E application after laser gingival depigmentation have any beneficial effect on

时间窗: All the clinical parameters will be assessed at 1 week, 2 weeks, 1 month and 3 months follow up

a) Wound healing

时间窗: All the clinical parameters will be assessed at 1 week, 2 weeks, 1 month and 3 months follow up

b) Degree of post-operative pain

时间窗: All the clinical parameters will be assessed at 1 week, 2 weeks, 1 month and 3 months follow up

c) Discomfort experienced by patients

时间窗: All the clinical parameters will be assessed at 1 week, 2 weeks, 1 month and 3 months follow up

次要结局

  • Hyaluronic acid gel application versus vitamin E application after laser gingival depigmentation result in Reduction in gingival inflammation

研究者

发起方
Dr Samiksha Mandavkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Samiksha Ashok Mandavkar

YMT Dental College and Hospital

研究点 (1)

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