Comparative Analysis of Topical Glutathione and Ascorbic Acid vs. Laser Therapy for Gingival Depigmentation: A Randomized Clinical Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Dummett oral pigmentation index(DOPI) Gingival pigmentation index(GPI)
研究概览
简要总结
Aim: To evaluate and compare efficacy of topical application of Glutathione combined with vitamin C versus laser therapy in the treatment of gingival depigmentation.
All the participants will be explained about the aim and procedure along with written informed consent for their participation before the commencement of study.
This study is a randomized clinical trial, conducted in healthy individuals with hyperpigmented gingiva, the study duration is 12months in which clinical parameters will be recorded at 4, 12 and 24 weeks.
This study will be performed in accordance with Helsinki declaration of 1975, as revised in 2013.
The clinical parameters assessed are:
-
Dummett oral pigmentation index
-
Gingival pigmentation index
-
Plaque index
-
Modified sulcular bleeding index
Initially, scaling will be done to ensure a plaque free operating site. After informing the procedure of depigmentation in detail, a written consent will be obtained from the patient. Before the procedure, the participants will be divided into Group A and Group B.
Group A: Laser Therapy
Gingival depigmentation will be performed using a diode laser with a wavelength of 810–980 nm.
The procedure will involve local anesthesia (Topical Spray-Lidocaine 15% w/w) followed by the laser ablation of the pigmented epithelium.
A single session will be conducted, lasting approximately 15–30 minutes, depending on the extent of pigmentation.
Postoperative care instructions will include avoiding spicy or hot foods and using an antiseptic mouthwash.
Group B: Topical Treatment (Glutathione + Ascorbic Acid)
A topical spray containing glutathione and ascorbic acid (ETHIGLO Spray, ETHICARE REMEDIES, Glutathione 50mg/ml, Vitamin C 20mg/ml).
The spray will be applied by a clinician for the first time to demonstrate how to be applied by the participant thereafter to the pigmented gingival areas twice a day for 4 weeks.
Participants will be instructed to avoid rinsing, eating, drinking, or brushing their teeth for 30 minutes’ post-application.
Post operative instructions will be given to the patients and patients are asked to report back incase of any discomfort.
All the participants will be recalled after 4, 12 and 24 weeks.
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
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Systemically healthy individuals Participants above 18 years Participants with physiologic melanin pigmentation Healthy gingival tissues without active Periodontal disease Participants with aesthetic concern.
排除标准
- •Pathological pigmentation of gingiva Clinically evident gingivitis Known allergic to glutathione and vitamin C Using tobacco in any form History of depigmentation procedures Pregnant and lactating women Systemic conditions and drugs affecting pigmentation.
结局指标
主要结局
Dummett oral pigmentation index(DOPI) Gingival pigmentation index(GPI)
时间窗: 4, 12 and 24 months
次要结局
- Patient satisfaction and acceptance questionnaire(Recurrence)
研究者
Dr Donepudi Sripragna
Narayana dental college and hospital