Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis

NCT06639009 | Recruiting DMC

• 2 other identifiers: AIIMSA2382AIIMS A2382
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Submucous Fibrosis

Keywords

Oral Submucous Fibrosis; trismus; Burning pain; diode laser; Photobiology; Electromyography; molecular biology; oral health

Outcome Measures

Primary Outcomes (1)

• Maximal Interincisal Mouth opening (mm):

  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.

  Baseline, after 1 and 3 months of PBMT

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Maximal Interincisal Mouth opening (mm):

  6 months and 1 year after PBMT

Study Arms (3)

Group A

SHAM COMPARATOR

Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management.

Other: 940nm diode laser photobiomodulation; Other: Conventional non -Invasive management in Oral Submucous fibrosis

Group B

ACTIVE COMPARATOR

Photobiomodulation therapy given intraorally (bilateral buccal mucosa) and extraorally (bilateral masseter muscle) with conventional non-invasive management.

Other: 940nm diode laser photobiomodulation; Other: Conventional non -Invasive management in Oral Submucous fibrosis

Group C

SHAM COMPARATOR

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.

Other: Conventional non -Invasive management in Oral Submucous fibrosis

Interventions

940nm diode laser photobiomodulation OTHER

The surgical handpiece (diameter 0.6cm) will be used without the fibre optic tips in defocused mode and head sanitized before therapy. Peak Power : 0.3Watts Power density: 1 Watt/cm2 Fluence: 4J/cm2 per cycle Spot size : 0.28cm2 Distance : 2mm from surface Mode: Continuous, Non- contact mode, circular motion, overlapping, in clockwise concentric manner with laser handpiece perpendicular to surface Duration of cycle : 25 seconds with interval of 30 seconds alternating with other side Cycles per sitting: Four for each side Four Sittings: Day 0,3, 7, and 15 Area of intervention: Bilateral buccal mucosa and masseter muscle Total treatment time per day: 430 seconds/ approx 7 minutes Total treatment time for 4 sittings: approx 28 minutes

Group A; Group B

Conventional non -Invasive management in Oral Submucous fibrosis OTHER

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 Control of systemic conditions 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

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Shalini Gupta: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Related Publications (3)

• Qin X, Ning Y, Zhou L, Zhu Y. Oral Submucous Fibrosis: Etiological Mechanism, Malignant Transformation, Therapeutic Approaches and Targets. Int J Mol Sci. 2023 Mar 5;24(5):4992. doi: 10.3390/ijms24054992.

  PMID: 36902423 BACKGROUND

• More CB, Das S, Patel H, Adalja C, Kamatchi V, Venkatesh R. Proposed clinical classification for oral submucous fibrosis. Oral Oncol. 2012 Mar;48(3):200-2. doi: 10.1016/j.oraloncology.2011.10.011. Epub 2011 Nov 8.

  PMID: 22070918 BACKGROUND

• Sukanya D, Upasana L, Deepak TA, Abhinethra MS, Choudary S. Determination of Effectiveness of Photobiomodulation in the Treatment of Oral Submucous Fibrosis. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S475-S478. doi: 10.4103/jpbs.jpbs_673_21. Epub 2022 Jul 13.

  PMID: 36110778 BACKGROUND

MeSH Terms

Conditions

Oral Submucous Fibrosis; Trismus; Pain

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shalini Gupta, MDS, FDSRCS(Edin)

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalini Gupta, MDS, FDSRCS(Erin)

CONTACT

919971904592; shalinigupta@hotmail.com

Savita Yadav, MD

CONTACT

919811797161; savita11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Additional Professor

Model Details: A patient and outcome assessor blinded, multiple- arm, randomized, placebo controlled clinical trial

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)