Comparison between Oral Pentoxifylline and Intralesional Injection Triamcinolone Hyaluronidase vs Intralesional Injection Triamcinolone + Hyaluronidase in Management of Oral Submucous Fibrosis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Therapeutic efficacy of Oral Pentoxifylline with Intralesional Injection Triamcinolone and Hyaluronidase compared With Intralesional injection Triamcinolone and Hyaluronidase alone over 4 weeks in the treatment of submucosal fibrosis. Assessment by Khanna and Andrade Classification of Submucosal fibrosis
研究概览
简要总结
60 study subjects will be included in the study and will be divided by double blind randomised manner, oral pentoxifylline with Intralesional injection Triamcinolone and hyaluronidase group compared with intralesional Injection Triamcinolone and hyaluronidase group. Decreased mouth opening using Khanna and Andrade stage will be recorded before and after 4 weeks of treatment. Intralesional injections will be given once a week and Tablet Pentoxifylline will be given thrice a day over 4 weeks. Oral Submucosal fibrosis stage wise division of patients will be done in randomised double blind manner.
All stages of OSMF will be included in this study. In patients with stage 5 OSMF, intralesional injection in both retromolar triangle will be given using a spinal needle. And in other stages, needle number 24 *1.5 inch will be used for intralesional injections in retromolar triangle.
All patients will be referred to physiotherapy OPD and will be given regular mouth opening exercises. All patients will be given oral antioxidants for 4 weeks.. Any adverse effects reported by the patients will be also noted. The data collected will be statistically analysed and response to pentoxifylline and Intralesional Triamcinolone and hyaluronidase compared with Intralesional Triamcinolone and hyaluronidase alone will be observed using khanna and Andrade classification of oral submucosal fibrosis( based on mouth opening between upper and lower incisors)
Grade/ Stage
Maximum interincisal mouth opening
I -Maximum interincisal mouth opening up to or > 35mm
II-Maximum interincisal mouth opening between 25 and 35mm
III-Maximum interincisal mouth opening between 15 and 25mm
IV- Maximum interincisal mouth opening 5 and 15mm
V-Maximum interincisal mouth opening <5 or nil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients clinically confirmed with oral submucosal fibrosis who have not undergone any previous treatment for the same.
排除标准
- •Congenital disease.
- •Pregnant and lactating woman.
- •Medical history of cardiovascular, gastrointestinal, nephrological and metabolic disorders.
- •Patients with coexisting orofacial disorders(including trauma)other than oral submucosal fibrosis that can interfere the study.
- •Patients with oral cancer.
结局指标
主要结局
Therapeutic efficacy of Oral Pentoxifylline with Intralesional Injection Triamcinolone and Hyaluronidase compared With Intralesional injection Triamcinolone and Hyaluronidase alone over 4 weeks in the treatment of submucosal fibrosis. Assessment by Khanna and Andrade Classification of Submucosal fibrosis
时间窗: 4 Weeks
次要结局
- Tobacco Chewing duration & stage of oral sub mucosal fibrosis.(4 Weeks)
研究者
Dr Aishwarya Chauhan Bhimji
GMERS Medical College and Hospital, Gotri, Vadodara