跳至主要内容
临床试验/CTRI/2024/06/069274
CTRI/2024/06/069274尚未招募4 期

Comparative evaluation of efficacy of topical triamcinolone and topical ozonated olive oil in management of recurrent aphthous stomatitis.

Shreeya Panchal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月1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
The patient will get relief from discomfort from aphthous ulcer

研究概览

简要总结

The study will aim to compare the efficacy of topical ozonated olive oil and topical triamcinolone acetonide in managing recurrent aphthous stomatitis (RAS). RAS, characterized by painful oral ulcers, lacks a specific cure, with treatments focused on symptom management. Corticosteroids, including triamcinolone acetonide, will be commonly used for RAS treatment due to their anti-inflammatory properties. Conversely, ozone therapy, aimed at enhancing oxygen levels and harnessing antimicrobial effects, will be gaining attention.

The sample size calculation will determine a total of 60 participants, divided equally into two groups: one treated with topical ozonated olive oil and the other with topical triamcinolone acetonide. The study will include individuals aged 16 years and above, without systemic diseases or medication for oral ulcers.

Data collection will involve assessing pain intensity using a visual analogue scale (VAS) and measuring ulcer size with a graded periodontal probe. Treatment application will occur four to five times daily until complete ulcer healing, with evaluations on the second, fourth, and sixth days.

Statistical analysis, to be conducted using SPSS version 23, will include descriptive statistics, frequency distribution, and independent sample t-tests for intergroup comparisons (p < 0.05).

The outcomes will focus on pain relief, ulcer size reduction, and healing duration. Pain intensity will be measured on a scale of 0-10, while ulcer size will be recorded at different time intervals.

In conclusion, the study will seek to provide insights into the comparative effectiveness of topical ozonated olive oil and topical triamcinolone acetonide in managing RAS. Results will contribute to understanding optimal treatment strategies for this prevalent oral condition, potentially improving patient comfort and quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Subjects in age group 14-70 years.
  • Subjects having one or more recurrent ulcers.
  • Subjects having duration of ulcer not more than 48 hours.
  • Subjects with painful ulcers causing discomfort.
  • Subjects should be healthy, with no systemic disease (diabetes) and immune-deficiency state.

排除标准

  • Patients suffering from systemic disorders which are known to cause ulcerations.
  • Patients who are already undergoing therapy for aphthous ulcers.
  • Patients presenting with chronic non-healing ulcers.
  • Patients reporting of ‘no pain/painless ulcer’.
  • Patients suffering from oral submucous fibrosis.
  • Pregnant women or lactating mothers.
  • Patients unable to attend multiple visits.

结局指标

主要结局

The patient will get relief from discomfort from aphthous ulcer

时间窗: 8 weeks

次要结局

  • Not applicable(Not applicable)

研究者

发起方
Shreeya Panchal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shreeya Panchal

Datta Meghe Institute of Higher Education and Research Centre, Sawangi, Wardha, Maharashtra

研究点 (1)

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