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临床试验/CTRI/2025/08/093309
CTRI/2025/08/093309尚未招募4 期

A Comparative Evaluation of Clinical Efficacy of Topical application of Propolis with triamcinolone acetonide in the management of symptomatic oral lichen planus: A Randomized Controlled Trial

Dr Sneha Sarang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
2. Erythema and ulceration

研究概览

简要总结

Oral lichen planus (OLP) is a chronic autoimmune disease causing inflammation on mucocutaneous area. The world prevalence for this lesion is 1.01%, more commonly found in women than men with a 2:1 ratio, respectively, and more common in age 30-60 years. OLP has been classified as an oral potentially malignant disorder with a malignant transformation rate ranging from 0 to 12.5% in different studies10 The etiology of this lesion remains unclear until today. However, few possible etiologies have been identified, such as hypersensitivity reaction, autoimmune reaction, psychological stress, and the still-debated viral infection. The widely recognized and generally accepted feature of OLP is related to its possible association with some psychological disorders, among which are anxiety, depression, and stress. As the exact causative factor for OLP is a matter of conflict, the failure to achieve appropriate or exact treatment for it may be the reason for its incomplete regression. The first line of treatment for OLP has been corticosteroids, but because of their adverse effects1 However, continuous and prolonged use is associated with many systemic adverse effects such as bad taste, nausea, facial swellings, SHORT STUDY SYNOPSIS OF PROPOSED TOPIC dryness, mucosal atrophy, candidal infection, granuloma formation, hypersensitivity reactions, delayed wound healing and in later stages; hypothalamus pituitary adrenal suppression ; alternative therapeutic approaches are being carried out. Recently, use of natural drugs, such as propolis, has gained considerable interest. Propolis is a resinous sticky substance produced naturally by bees, and it consists of the exudates of plants mixed with enzymes, wax, and pollen. The term “propolis” is Greek in origin and, in the context of bees, means “defense of the hive.” As the term suggests, propolis is used by bees for hive protection against bacteria, viruses, fungi, and parasites1. It is collected by the honey bees from the sap, leaves, and buds of plants, and then mixed with secreted beeswax. It has been used in folk medicine for thousands of years and is also known as Russian penicillin1. Propolis being very high in bioflavonoid content has antioxidant, antibacterial, antifungal, antiviral, immunomodulatory and anti-inflammatory properties. These properties have prompted investigators to check its efficacy on various oral diseases, namely oral lichen planus (LP), oral candidiasis, recurrent aphthous stomatitis, radiation mucositis16, denture stomatitis, and herpes labialis Furthermore, there is growing interest within the dental field in the use of natural medicinal products with inherent antimicrobial activity, such as propolis. it not only represents a promising alternative antimicrobial agent but also has a range of favorable biological activities, making its use in preventing or treating various dental and oral conditions1. “This Study aims to provide an overview of the applications of propolis in the symptoms of OLP and highlighting its clinical effectiveness and identifying research gaps that need to be addressed”

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients with clinically diagnosed atrophic/erosive OLP(based on modified WHO clinical criteria, 2003) 2 Individuals willing to be a part of the study, who sign the informed consent form, and who find it convenient to appear for follow-ups as required by the study.
  • 3 Patients who had not used systemic or topical glucocorticosteroids for at least the past 2 weeks 4 Patients who agree not to use any other medication such as analgesics and Anesthetics in either topical form or systemic form during the study.

排除标准

  • 1 Patients with lichenoid lesions thought to arise as a hypersensitivity reaction to drugs and dental materials 2 Patients on long-term glucocorticosteroid therapy 3 Pregnant and lactating female patients 4 Patients allergic to bee products.

结局指标

主要结局

2. Erythema and ulceration

时间窗: The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded.

To evaluate the efficacy of topical propolis in comparison with topical triamcinolone acetonide in symptomatic oral lichen planus in following parameters

时间窗: The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded.

1. Pain

时间窗: The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded.

3. Side effects

时间窗: The active treatment duration for each group will be for a period of 15 days. The patients will be recalled and scheduled for an appointment on 7th and 15th day and the clinical evaluation will be done and recorded.

次要结局

未报告次要终点

研究者

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

Dr Sneha Sarang

Sinhgad dental college and hospital, Pune

研究点 (1)

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