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临床试验/NCT04126720
NCT04126720已完成1 期

Evaluation of Salivary Total Oxidant Capacity in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid Supplemented With Vitamin E Versus Topical Corticosteroid Alone

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Pain measure using numerical rating scale

研究概览

简要总结

Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available.

In some oral lichen planus patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect.

This trial will assess the effectiveness of vitamin E as a supplement in management of oral lichen planus.

详细描述

The current study is a randomized-controlled clinical trial that follows CONSORT guideline. The current trial include 30 symptomatic OLP patients in two parallel groups (intervention - topical triamcinolone acetonide adhesive paste and Vitamin E capsule, control - topical triamcinolone acetonide adhesive paste and placebo capsule), with allocation ratio 1:1. Participants were recruited from the pool of the Diagnostic center and the Out-Patient Clinic of Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University, Egypt between 2016 and 2017.

This clinical trial followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University, Egypt (Code: 15733). Each participant was informed about the details of the study and signed a written consent.

Patients were diagnosed clinically and histopathologically (when required). Inclusion criteria included erosive and atrophic OLP patients who agreed to take supplied medications. Exclusion criteria included reticular OLP patients, patients receiving systemic treatment for OLP during the eight weeks prior to the study, patients receiving topical medications for OLP during the four weeks prior to the study, patients suffering from systemic disease; pregnant ladies and lactating ladies.

Interventions:

The intervention was 0.1% triamcinolone acetonide adhesive paste (Kenacort A Orabase - Dermapharm) and 400 mg Vitamin E capsule (Vitamin E 400 - Pharopharmaceuticles) for the experimental group and 0.1% triamcinolone acetonide adhesive paste (Kenacort A Orabase - Dermapharm) and identical placebo capsule for the control group.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients clinically and histopathologically diagnosed as suffering from OLP (erosive and atrophic OLP patients who agreed to take supplied medications).
  • Patients free from any visible oral lesions other than OLP.
  • Patients who agreed to take supplied medications.
  • Patients who agreed for the biopsy

排除标准

  • Reticular OLP patients
  • Patients suffering from any systemic disease.
  • Patients Treated with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
  • Treatment with any oral topical medications for at least four weeks prior to the study.
  • Pregnant and lactating mothers

研究组 & 干预措施

vitamin E

Active Comparator

topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermapharm) four times daily and Vitamin E capsule (Vitamin E 400: 400 mg vitamin E capsules - Pharopharmaceuticles) daily.

干预措施: topical corticosteroids and vitamin E suplements (Dietary Supplement)

Placebo

Placebo Comparator

topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% 5 gram adhesive paste - Dermapharm) four times daily and placebo capsule daily

干预措施: Topical corticosteroid and placebo capsules (Drug)

结局指标

主要结局

Pain measure using numerical rating scale

时间窗: weekly for 1 month

All patients will be asked to define their level of pain and discomfort by using a numerical rating scale ranging from 0 to 10 (11-point), with 0 indicating "no pain" and 10 indicating "pain as bad as you can imagine

次要结局

  • salivary total anti-oxidant capacity(Preoperative and postoperative)
  • Clinical improvement of the lesion(weekly for 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Engy Mahmoud Abdel Wahed Abdel dayem

assistant lecturer

Cairo University

研究点 (1)

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