To Determine and Compare the Adjunctive Effect of Photobiomodulation With 940nm Diode Laser on Maximal Interincisal Mouth Opening Versus Conventional Non-invasive Management in Moderate Oral Submucous Fibrosis: A Patient and Outcome Assessor Blinded, Multiple- Arm, Randomized, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 315
- 试验地点
- 2
- 主要终点
- Maximal Interincisal Mouth opening (mm):
研究概览
简要总结
This a patient and outcome assessor blinded, multiple arm, randomized placebo controlled clinical trial.
The goal of the study is to study the adjunctive effect of 940nm laser photobiomodulation therapy (PBMT) in precancerous condition like moderate Oral submucous Fibrosis in increasing the mouth opening. It will also assess the the effect of PBMT on oral burning sensation cheek flexibility, electromyography of bilateral masseter muscle, inflammatory and fibrogenic cytokines and oral health quality of life at baseline and after 1 and 3 months of PBMT.
Adult subjects fulfilling the selection criteria will be prospectively recruited after ethical clearance and informed written consent. They will be randomized into 3 groups in 1:1 :1 distribution
The three groups are as follows:
Group A: Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management.
Group B: Photobiomodulation therapy given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management.
Group C: Sham (Use of laser handpiece with only red guide light and without using the foot pedal which activates the laser)Photobiomodulation therapy(Placebo) (Intraoral and Extraoral) with conventional non-invasive management.
The conventional non invasive management in Oral submucous fibrosis which all the groups will receive are as follows:
Brief behavioral Tobacco, areca nut and alcohol habit cessation counseling as per WHO 5As and 5Rs technique at baseline and each follow up.
Oral prophylaxis Removal of oral irritational factors like sharp teeth, appliances or prosthesis, impacted buccoverted third molars, parafunctional habits Oral hygiene maintenance instructions Oral physiotherapy(Mouth opening and cheek ballooning exercises) Control of systemic conditions (Anemia, Diabetes, hypertension, thyroid disorders) by specialist referral Removal of all predisposing factors for oral candida infection Advocacy for safe sexual practices Nutrition and diet counseling( seasonal and regional food rich in nutrients, vitamins, antioxidants avoidance of spicy /sour/ hot foods and drinks) Regular surveillance for malignant transformation All the outcome parameters will be assessed at baseline and 1 and 3 months after PBMT.
详细描述
Study design:
A patient and outcome assessor blinded, multiple- arm, randomized, placebo controlled clinical trial Setting: All India Institute of Medical sciences New Delhi
Selection of patients:
Consecutive patients diagnosed with Oral Submucous Fibrosis based on WHO clinical criteria (Warnakulsurya et al 2007, 2021) and classified as Moderate Oral Submucous Fibrosis based on functional staging of More et al 2011 (Functional staging M2 and M3: maximal interincisal distance 15-35 mm) will be prospectively recruited after ethical clearance and informed written consent.
Clinicopathologic characteristics:
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
- Double (Participant, Outcomes Assessor)
盲法说明
The subjects will be blinded to the group assignment as they will receive PBMT ( Active or Sham as per group assignment ) both intraorally and extraorally The outcome assessor will be blinded to the group assignment of the subjects as they will be identified by unique randomization code only
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with symptomatic bilateral Moderate≥ 18 years of age Subjects who have had no medical, surgical or physical intervention for OSMF at least three months prior to participation in this study.
- •Subjects willing to participate in the study
排除标准
- •Subjects with any other Oral potentially malignant disorders ( Leukoplakia/ Oral lichen planus etc ) other than OSMF.
- •Subjects with OSMF with dysplasia in previous biopsy, suspicious lesion that requires biopsy for histopathological examination Subjects with any current / past history of any malignancies Subjects with any developmental disorders, cranio-maxillomandibular bony pathologies/ trauma, current odontogenic / maxillofacial infection or surgeries causing trismus Subjects with uncontrolled systemic diseases, psychiatric disorders o Subjects with open wounds on the sites to be exposed to LASER PBM or to EMG. Subjects with any scars, tattoos, moles, traumatic, ulcerative, pathological skin lesion on facial skin in region of masseter muscle Subjects unwilling to shave facial hair for electromyography. Subjects with history of Autoimmune diseases like Scleroderma, Dermatomyositis, oral vesiculobullous and Behçet's disease Subjects with history of any corticosteroid, immunosuppressive, anti inflammatory ,immune modulating medication in past six months Subjects with Temporomandibular Joint disorders, Cervical spondylosis muscle dystrophy or any neuromuscular disorders Pregnancy
结局指标
主要结局
Maximal Interincisal Mouth opening (mm):
时间窗: Baseline, after 1 and 3 months of PBMT
It is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite It will be measured using Vernier calipers as described by Wood et al.
次要结局
- Cheek Flexibility (mm):(Baseline, after 1 and 3 months of PBMT)
- Visual Analogue Score for Pain (0-10):(Baseline, after 1 and 3 months of PBMT)
- Visual Analogue Score for Burning Sensation (0-10):(Baseline , after 1 and 3 months of PBMT)
- Electromyography evaluation of Masseter Muscle (μV):(Baseline , after1 and 3 months of PBMT)
- Molecular characteristics of inflammatory and fibrogenic salivary cytokines (IL6, TNFα, TGFβ, CTGF) pre and post PBM therapy(Baseline, after1 and 3 of PBMT)
研究者
Dr. Shalini Gupta
Additional Professor
All India Institute of Medical Sciences, New Delhi