CTRI/2025/03/082470 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On:
14/03/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Dentistry Physiotherapy (Not Including YOGA)
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Effectiveness of Laser Therapy and Exercises in Improving Mouth opening restriction in Oral Submucous Fibrosis
Scientific Title of Study
EFFECTIVENESS OF LOW INTENSITY LASER THERAPY IN COMBINATION WITH SOFT TISSUE MOBILIZATION AND MOUTH OPENING EXERCISES FOR MANAGING TRISMUS IN ORAL SUBMUCOUS FIBROSIS: A RANDOMIZED CONTROLLED TRIAL
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
nil
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Departmental Ethical Committee, Faculty of Physiotherapy , SGT University
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M628||Other specified disorders of muscle,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Group A - Low intensity Laser, Soft tissue mobilization and mouth opening exercises
The Experimental Group (Group A) will receive Low-Intensity Laser Therapy (LILT) along with Soft Tissue Mobilization and Mouth Opening Exercises for four weeks. LILT will be applied for 8 minutes on the buccal mucosa using a wavelength of 810 nm, a frequency of 1500 Hz, and an energy density of 1575 mJ. Soft Tissue Mobilization will be performed for 20 minutes, including 6 minutes of fingertip and thumb tip kneading (3 minutes each), 10 repetitions × 2 sets of wide mouth opening (3.5 minutes), lateral deviation of the mandible to the right and left (3.5 minutes), mandibular protrusion (3.5 minutes), and gradual mouth stretching (3.5 minutes). Additionally, Mouth Opening Exercises will be performed for 12 minutes, consisting of tongue press against a stick, cheek resistance push, lateral tongue stretch, cheek balloon exercise, pucker, lip circle exercise, lip hold, up-and-down tongue stretch, and tongue glide over teeth, each done for 10 repetitions × 1 set with 1-minute duration and 20 seconds of resting time. The intervention will be conducted three times per week (Monday, Wednesday, and Friday), with a Home Exercise Program (HEP) on alternate days (Tuesday, Thursday, and Saturday).
Comparator Agent
Group B- Soft tissue mobilization and mouth opening exercises
The Control Group (Group B) will receive only Soft Tissue Mobilization and Mouth Opening Exercises following the same schedule as Group A, without the application of LILT. Soft Tissue Mobilization will be performed for 20 minutes, including 6 minutes of fingertip and thumb tip kneading (3 minutes each), 10 repetitions × 2 sets of wide mouth opening (3.5 minutes), lateral deviation of the mandible to the right and left (3.5 minutes), mandibular protrusion (3.5 minutes), and gradual mouth stretching (3.5 minutes). The Mouth Opening Exercises will be identical to those performed in Group A, lasting 12 minutes, with exercises such as tongue press against a stick, cheek resistance push, lateral tongue stretch, cheek balloon exercise, pucker, lip circle exercise, lip hold, up-and-down tongue stretch, and tongue glide over teeth, all performed for 10 repetitions × 1 set with 1-minute duration and 20 seconds of resting time. Treatment will be administered three times per week (Monday, Wednesday, and Friday), with a Home Exercise Program on non-treatment days (Tuesday, Thursday, and Saturday). Outcome measures, including mouth opening, cheek flexibility, tongue protrusion, pain (VAS), and maximum bite force, will be assessed at baseline, and at the end of the 4th week.
Inclusion Criteria
Age From
23.00 Year(s)
Age To
56.00 Year(s)
Gender
Both
Details
1.Patients who are diagnosed clinically for Oral submucous fibrosis.
2.Patients who will give the consent and are ready for regular follow-up.
3.Individuals with or without Pain in buccal mucosa.
4.Individuals with associated complaint of Inability to open mouth on Stage of 1,2 and 3 of the Classification of OSMF by More et al (2012)
5.Individuals who are eligible for the study as per criteria of Gothenburg trismus questionnaire.
ExclusionCriteria
Details
1.Patients with reduced mouth opening due to other problems than Oral submucous fibrosis.
2.A patient who declined to fill the consent form
3.Patients who are suffering with any TMJ dysfunction
4. OSMF patients with malignant transformation.
5.Patients who were on medication from last 1 week. (NSAIDS)
6.Patient who had underwent fibrotomy procedure.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
Mouth Opening
Tongue protrusion
Day 1 assessment
end of 4th week
Secondary Outcome
Outcome
TimePoints
Burning Sensation
Cheek Flexibility
Maximum bite force
Quality of life
Day 1 assessment
end of 4th week
Target Sample Size
Total Sample Size="28" Sample Size from India="28" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 2
Date of First Enrollment (India)
25/03/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Oral submucous fibrosis (OSMF) is a chronic, debilitating disease characterised by juxtaepithelial fibrosis of the oral cavity. It is regarded as a precancerous and potentially malignant condition. Oral submucous fibrosis (OSMF) may be defined as an insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx. Although occasionally preceded by and/or associated with vesicle formation, it is always associated with a juxta-epithelial inflammatory reaction followed by a fibroelastic change of the lamina propria, with epithelial atrophy leading to stiffness of the mucosa and causing trismus and inability to eat. The definition by the WHO of an precancerous oral condition: “a generalized pathological state of the oral mucosa associated with a significantly increased risk of cancer” fits well with the characteristics of OSMF . The characteristic features of Oral submucous fibrosis are loss of pigmentation, blanching and leathery texture of oral mucosa, depapillation and reduced movement of tongue, progressive reduction of mouth opening and sunken cheeks. The prevalence rate in India is about 0.2–0.5 % with prevalence by gender varying from 0.2 to 2.3 % in males and 1.2 to 4.57 % in females and malignant transformation rate of 7–30 % . OSMF is a disease of middle age group with peak incidence observed in the second to fourth decade of life. The sex distribution of OSMF varies geographically. The most common oral site for OSMF is buccal mucosa and retromolar region, followed by soft palate, faucial pillars, floor of mouth, tongue, labial mucosa and gingiva. Clinical presentation depends on the stage of the disease. Initially, most patients present with a burning sensation or intolerance to spicy food, and they may have vesicles, particularly on the palate. Ulceration and dryness of the mouth is later followed by fibrosis of the oral mucosa, which leads to rigidity of the lips, tongue, and palate, and trismus. A useful clinical sign is pain on palpation in the sites where submucosal fibrotic bands are developing, and trismus is caused mostly by fibrosis in the dense tissue around the pterygomandibular raphae. Fibrosis of the eustachian tube may lead to deafness. When the fibrosis involves the nasopharynx or oesophagus, patients may experience referred pain to the ear, a nasal voice, and dysphagia to solids; usually these are features of more advanced disease. The etiology of OSMF is obscure, although various hypotheses are proposed, suggesting multifactorial origins, such as chewing of areca nut and its flavored formulations (most common), chronic nutritional deficiencies (especially iron, Vitamin B complex and protein) and genetic predisposition, autoimmunity Excessive use of areca nut and its flavored formulations disrupts the hemostatic equilibrium between synthesis and degeneration. The copper ion in areca nut increases the activity of lysyl oxidase leading to unregulated collagen production, thereby causing oral fibrosis. This leads to the production of free radicals and reactive oxygen species, which are responsible for high rate of oxidation– peroxidation of polyunsaturated fatty acids. OSMF is a disease of middle age group with peak incidence observed in the second to fourth decade of life. The sex distribution of OSMF varies geographically. The most common oral site for OSMF is buccal mucosa and retromolar region, followed by soft palate, faucial pillars, floor of mouth, tongue, labial mucosa and gingivaTo predict scoring index, OSMF where O— corresponds to interincisal mouth opening, S—involvement of site in the oral cavity, M—malignant changes if any and F denotes severity of fibrous bands . Submucous Fibrosis (OSMF) is categorized into distinct grades based on clinical and functional staging criteria, providing clinicians with valuable insights into disease severity and progression. One widely accepted classification system divides OSMF into several grades, each associated with specific mouth opening ranges. Grade I, representing the early stage, is characterized by subtle clinical signs such as blanching of the oral mucosa and palpable fibrous bands, often accompanied by mild symptoms like a burning sensation during mastication. Progression to Grade II, the moderate stage, is marked by more pronounced mucosal changes, including restricted mouth opening (trismus) and increased rigidity, with the mouth opening range typically mildly reduced, often between 30-35 mm. Grade III signifies the advanced stage, featuring severe fibrosis and functional impairment, with significantly restricted mouth opening, typically between 20-25 mm, and widespread thickening of fibrous bands. Finally, Grade IV, the severe stage, reflects extensive fibrosis, complete oral vestibule obliteration, and severe trismus, severely compromising oral function, with mouth opening range being severely restricted, often less than 10 mm or even absent. Physiotherapy is a non invasive modality which may aid in the symptomatic treatment of patients with OSMF . The aim of this study is to assess the effectiveness of laser therapy versus ultrasound in combination with soft tissue mobilization and mouth opening exercises for managing trismus in oral submucosal fibrosis.
Null Hypothesis
H01 -There will not be any significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in managing trismus in patients with oral submucous fibrosis.
H02- There will not be any significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in patients with oral submucous fibrosis for managing mouth opening and tongue protrusion.
H03- There will not be any significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in managing pain, cheek flexibility, strength of facial muscles, maximum bite force and quality of life in patients with Oral submucous fibrosis.
Alternate Hypothesis
H1 -There will be significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in managing trismus in patients with oral submucous fibrosis.
H2- There will be significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in patients with oral submucous fibrosis for managing mouth opening and tongue protrusion.
H3 - There will be significant effect of low intensity laser therapy combined with soft tissue mobilization and mouth opening exercises in managing pain, cheek flexibility, strength of facial muscles, maximum bite force and quality of life in patients with Oral submucous fibrosis.