The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Severity of clinical presentation of the lesion
研究概览
简要总结
The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment
详细描述
The objective of the research:
To investigate the role of vitamin D supplements in the management of vitamin D deficient oral lichen planus (OLP) patients and to examine its suppressive effect on pro-inflammatory cytokine (IFN-γ) in saliva samples of OLP patients
• Steps in short
1- Trial design: This study is a randomized clinical trial (RCT) having parallel groups with a 1:1 allocation ratio. This study will conform with the Consolidated Standards of Reporting Trials guidelines (CONSORT guidelines).
Middle-aged patients presenting with clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP (32) and having vitamin D deficiency or insufficiency (≤30 ng/ml) (33) will be included in the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Middle-aged patients
- •Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP
- •Vitamin D deficiency or insufficiency (≤30 ng/ml)
排除标准
- •Oral mucosal lesion other than OLP
- •Suspected restoration-related reaction
- •Active periodontitis
- •Patients receiving any topical or systemic medication that may affect SVDL or induce a lichenoid reaction
- •Patient having systemic disease based on the detailed questionnaire of the modified Cornell Medical Index
研究组 & 干预措施
Vitamin D+ Systemic steroids
vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.
干预措施: vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone (Drug)
Vitamin D+ Systemic steroids
vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.
干预措施: Systemic prednisone (Drug)
Systemic steroids alone
systemic steroids only
干预措施: Systemic prednisone (Drug)
结局指标
主要结局
Severity of clinical presentation of the lesion
时间窗: 1 months
The severity of the clinical presentation of the lesion was calculated by multiplying (Sub-site score A) by (Severity score B) as Sub-site score A 0= no lesion 1. evidence of lichen planus 2. ≥50% of buccal mucosa, dorsum of the tongue, the floor of the mouth, hard palate, soft palate, or oropharynx affected Severity score B 0= keratosis only 1. keratosis with mild erythema (≤ 3 mm from gingival margin) 2. marked erythema (e.g. full thickness of gingivae, extensive with atrophy or edema on non-keratinized mucosa) 3. ulceration present Severity of clinical appearance=A\*B (sub-site score\* severity score) * Mild: 1-2 * Moderate: 3-4 * Severe: 5-6 Finally, the lesion was considered as persisting at follow-up if the clinical presentation score was greater than 0 where whereas a score of 0 indicated a healed lesion.
Pain and burning sensation
时间窗: 1 months
VAS score or burning sensation and pain ranging from 0 to 10 * Mild : 0-4 * Moderate: 5-7 * Severe: 8-10
次要结局
- Changes in salivary INF-γ level(1 months)
研究者
Rania Hassan Shalby
Lecturer of Oral Medicine
Fayoum University