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临床试验/CTRI/2024/06/068605
CTRI/2024/06/068605尚未招募不适用

Comparative evaluation of the effect of Blue M active oxygen gel and coe-pack dressing on postoperative surgical depigmentation healing-A Clinical Study

DR TUSHARIKA SHARMA1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年6月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
34
试验地点
1
主要终点
Dummett gupta oral pigmentation index

研究概览

简要总结

Topical anesthesia was applied with 2% lidocaine, and the entire pigmented layer of gingival epithelium in addition to an underlying layer of connective tissue was removed by abrasion with a no. 15 surgical blade. The depigmentation procedure was performed from the mucogingival junction to the base of the interdental papilla. Direct pressure was applied with a sterile gauze to control hemorrhage during the surgical procedure .The depigmented

area was covered with the conventional Coe-Pak periodontal dressing in the control group, whereas the Blue M active oxygen gel was applied to cover the depigmented area in the test group. Patient will be asked to apply Blue M active oxygen gel three times per day for one week at home. Patients will be recalled for follow up visit after 24 hours and 1 week postoperatively for the removal of Coe-pak dressing.

研究设计

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

入排标准

年龄范围
20.00 Year(s) 至 38.00 Year(s)(—)
性别
All

入选标准

  • •Patients with gingival hyperpigmentation Patient with scoring criteria for Dummet Oral Pigmentation index more than 1.

排除标准

  • •Smokers Pregnant and lactating women Medically compromised patients Those with a history of periodontal surgery in less than three months Those with gingival pigmentation associated with other syndromes and lesions Those with a score of more than one for plaque and gingivitis indices Those with a score of less than three for DOP index.

结局指标

主要结局

Dummett gupta oral pigmentation index

时间窗: baseline , 1week , 2 weeks , 3 weeks and 1 month

次要结局

  • Visual Analog Scale, VAS (Steigmann 1965)(after 2 hrs , after 24 hrs , 2 days , 3 days and 7 days)
  • Re-epithelization index study Sridharan and Shankar, 2012(baseline , 1week , 2 weeks , 3 weeks and 1 month)

研究者

发起方
DR TUSHARIKA SHARMA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tusharika Sharma

KM SHAH DENTAL COLLEGE AND HOSPITAL

研究点 (1)

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