FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  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)  
Name  Astha Mahajan 
Designation  PG student 
Affiliation  Sgt university, Gurgaon 
Address  Room no. 13, Faculty of Physiotherapy,Shree Gobind Singh Tricentenary Univerity,Budhera Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  9870438811  
Fax    
Email  aasthamahajan214@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Rishi 
Designation  Associate Professor 
Affiliation  Sgt university, Gurgaon 
Address  Room No. 13, Faculty of Physiotherapy,Shree Gobind Singh Tricentenary Univerity, Budhera, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  8588878467  
Fax    
Email  priyanka.physio@sgtuniversity.org  
 
Details of Contact Person
Public Query
 
Name  Dr Anushree Rai 
Designation  Assistant Professor 
Affiliation  Sgt university, Gurgaon 
Address  Room no. 13, Faculty of Physiotherapy,Shree Gobind Singh Tricentenary Univerity,Budhera, Gurgaon

Gurgaon
HARYANA
122505
India 
Phone  8937881164  
Fax    
Email  anushree.rai.21@gmail.com  
 
Source of Monetary or Material Support  
Faculty of Physiotherapy, SGT University, Chandu, Budhera, Gurgaon , 122505 
 
Primary Sponsor  
Name  Astha Mahajan 
Address  Faculty of Physiotherapy, Shree Gobind Singh Tricentenary University, Gurugram 122505 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Astha Mahajan  SGT Hospital  Room no. 13, Faculty of Physiotherapy, Shree Gobind Singh Tricentenary Univerity,Budhera,Gurgaon
Gurgaon
HARYANA 
9870438811

aasthamahajan214@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 gingiva To 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.

 

 
Close