Comparative Evaluation of Topical Platelet Rich Fibrin in Orabase Versus 0.1 percent Topical Triamcinolone Acetonide in Orabase for management of Oral Lichen Planus - A Randomised Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- VAS score, Thongprasom score, number, clinical appearance, and recurrence of lesion
研究概览
简要总结
56 Clinically and histopathologically proven cases of oral lichen planus reporting to department of Oral Medicine and Radiology will be recruited to the study. Followed by Baseline assessment of clinical parameters (VAS SCORE, THONGPRASOM SCORE, NUMBER OF LESION AND CLINICAL APPEARANCE). Randomized allocation of subjects into two groups: Group I of 28 subjects will be treated with Topical PRF-minced and mixed 1:1 w/w with orabase applied thrice daily till clinical resolution is achieved upto a maximum of 8 weeks and Group II of 28 subjects will be treated with Topical 0.1 % triamcinolone acetonide in orabase twice a day till clinical resolution is achieved upto a maximum of 8 weeks.For both the groups at the end of every week for eight weeks all the outcomes parameters (VAS SCORE, THONGPRASOM SCORE, NUMBER OF LESION AND CLINICAL APPEARANCE ) will be assessed and subsequently once a month for six months followed by Statistical Analysis
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.Subjects aged 18 to 60 years of both genders, diagnosed with symptomatic oral lichen planus clinically and histopathologically confirmed according to Modified WHO criteria.
- •2.Subjects who voluntarily consented to be a part of the study.
排除标准
- •1.Subjects who have received any topical treatment for OLP within the last 2 weeks or any systemic treatment for OLP within the past 3 months.
- •2.Subjects who are having Oral lichenoid reactions due to any medications, dental materials, diseases such as GVHD, tobacco, and so on.
- •3.Subjects with oral mucosal lesions other than OLP.
- •4.Subjects with a history of Anaemia (Hb less than 11g/dl) and Platelet count less than 150,000/mm3 5.Subjects with history of any medication, or conditions associated with bleeding disorders.
- •6.Subjects on anticoagulant therapy, chemotherapy or immunosuppressive medications.
- •7.Subjects with other autoimmune disease, malignancy, or hepatitis C virus infection.
- •8.Subjects for whom phlebotomy is contraindicated: evidence of cellulitis or abscess, presence of hematoma, presence of scar, recent venipuncture at the same location.
- •10.Subjects receiving any systemic steroids for other systemic diseases.
- •11.Pregnant and lactating women.
- •12.Subjects with a habit of smoking.
结局指标
主要结局
VAS score, Thongprasom score, number, clinical appearance, and recurrence of lesion
时间窗: At the end of 0,1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 1 month, 2nd month,3rd month, 4 th month, 5th month, 6th month
次要结局
- Adverse effects if any(At the end of 0,1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 1 month, 2nd month,3rd month, 4 th month, 5th month, 6th month)
研究者
Dr Suman B
Government Dental college and Research Institute, Bangalore