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临床试验/CTRI/2025/08/092428
CTRI/2025/08/092428已完成不适用

Clinical and histological assessment and comparison of healing after gingival depigmentation following application of recombinant epidermal growth factor gel and oxygen releasing gel.

Institute of Dental Studies and Technologies1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Dumett Gupta Index score

研究概览

简要总结

This study was conducted by Dr. Shweta Gupta, Dr. Narender, Dr. Manish Khatri, Dr. Mansi Bansal, Dr Pratiksha Tripathi at Department Of Periodontology, Institute of Dental Studies & Technologies, Modinagar, Uttar Pradesh, India

The purpose of this study is to clinically evaluate and histologically assess and compare the healing after gingival depigmentation following application of recombinant epidermal growth factor gel and oxygen releasing gel.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • Systemically and periodontally healthy patients.
  • Patients with well maintained oral hygiene.
  • Patients with aesthetic concerns having moderate to severe(score 2 or 3) gingival pigmentation of maxillary or mandibular anterior gingiva based on Dumett Gupta (1964).

排除标准

  • Patients with thin gingival biotype.
  • Patients with missing anterior teeth.
  • Patients who are current or former smokers.
  • Pregnant and lactating females.
  • Non-compliant patients.
  • Patients with any metallic restoration or undergoing orthodontic therapy.

结局指标

主要结局

Dumett Gupta Index score

时间窗: Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day

Healing Index (Landry et al)

时间窗: Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day

Visual Analogue Scale scores

时间窗: Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day

Epithelization test (Toluidine Blue and Hydrogen

时间窗: Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day

peroxide)

时间窗: Baseline, 3rd day, 5th day, 7th day, 10th day, 30th day, 90th day

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Shweta Gupta

Institute of Dental Studies and Technologies

研究点 (1)

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