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临床试验/CTRI/2024/05/067411
CTRI/2024/05/067411尚未招募不适用

“Comparative Evaluation of Gingival Depigmentation By Scalpel And Microneedling With Ascorbic Acid”

Saveetha dental college and hospital SIMATS University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年5月30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
16
试验地点
1
主要终点
Intensity of pigmentation

研究概览

简要总结

Background: Gingival pigmentation, characterized by the presence of melanin in the gingival tissues, is a common aesthetic concern in dental practice. While it poses no inherent health risks, the visible discoloration may cause psychological distress for individuals seeking optimal dental aesthetics. Understanding the efficacy of various methods is essential for refining treatment strategies and enhancing patient satisfaction in the realm of gingival depigmentation.

Aim: The objective of the study is to compare the effectiveness of scalpel and microneedling with ascorbic acid in the treatment of gingival depigmentation.

Materials and Methods: Sixteen patients who had a complaint of gingival pigmentation were included in the study, out of which 8 patients were allocated for scalpel group and the other 8 patients were treated with microneedling technique with ascorbic acid. Postoperative wound healing scores were evaluated at the 1st and 7th day respectively. Intensity of depigmentation was assessed at baseline, 1st month and at the end of 3rd month respectively.

Results: The mean DOPI score in the baseline were 2.65±0.16 and 2.61± 0.17 in the surgical and MN with ascorbic acid groups respectively. The mean DOPI score at the end of 3rd month was 1.67 ±0.39 and 0.87± 0.17 in the surgical and MN with ascorbic acid groups respectively. There was a statistically significant difference between the scalpel and MN & ascorbic acid groups at the end of 1st month and 3rd month respectively with MN & ascorbic acid showing esthetically pleasing outcomes. Patients treated with scalpel technique showed incomplete healing and ulceration on 1st and 7th day after the procedure when compared to the microneedling technique with ascorbic acid. Healing index scores were statistically significant in the MN & ascorbic acid group.

Conclusion: Microneedling technique with ascorbic acid is a successful technique in treating gingival depigmentation. It showed esthetically gratifying outcomes when compared to the conventional surgical technique.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 and above; 2) demonstrated systemic health; and 3) exhibited physiologic gingival hyperpigmentation within the aesthetic zone.

排除标准

  • systemic disorders, particularly patients with bleeding disorders; 2) individuals undergoing chemotherapy; 3) pregnant women 4) smokers; and 5) gingivitis and periodontitis patients.

结局指标

主要结局

Intensity of pigmentation

时间窗: baseline, 1 month, 3 months

次要结局

  • wound healing(1st day, 7th day)

研究者

发起方
Saveetha dental college and hospital SIMATS University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Swarna Meenakshi p

saveetha dental college, SIMATS Universitychennai

研究点 (1)

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