Effect of Laser Photobiomodulation in Improving Mouth Opening in Oral Submucous Fibrosis
ConditionOral Submucous Fibrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorDr. Shalini Gupta
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
940nm diode laser photobiomodulation
Other interventionThe 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
Conventional non -Invasive management in Oral Submucous fibrosis
Other interventionBrief 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
Treatment groups
315 Participants
are divided into 3 treatment groupsGroup A: Group ASham comparator 2 interventions
Group B: Group BActive comparator 2 interventions
Group C: Group CSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, after 1 and 3 months of PBMTSecondary outcomes
1
Cheek Flexibility (mm):
Cheek Flexibility (mm): Measurement of Cheek flexibility was done in accordance with the method by Mathur and Jha: Cheek flexibility = V1-V2. Two points measured at one-third the distance from the angle of the mouth on a line joining the tragus of the ear and the angle of the mouth (V2). The subject is then asked to blow his cheeks fully and the distance measured between the two points marked on the cheek (V1)
Time frame
Baseline, after 1 and 3 months of PBMT2
Visual Analogue Score for Pain (0-10):
Clinical evaluation for burning sensation will be done by visual analog scale (VAS) which is a numeric rating scale of 0-10 scores, where 0 means no symptoms and 10 means severe symptoms as perceived by the individual.
Time frame
Baseline, after 1 and 3 months of PBMT3
Visual Analogue Score for Burning Sensation (0-10):
Clinical evaluation for burning sensation will be done by visual analog scale (VAS) which is a numeric rating scale of 0-10 scores, where 0 means no symptoms and 10 means severe symptoms as perceived by the individual.
Time frame
Baseline , after 1 and 3 months of PBMT4
Electromyography evaluation of Masseter Muscle (μV):
Electromyography evaluation of Masseter Muscle (μV): Subjects will be instructed to maintain a natural head position shielded room to eliminate outside electrical interferences. To place the electrodes, the test, which consists of muscular palpation during simultaneous bilateral isotonic contraction, will be performed. For the masseter, electrodes will be placed between the gonion and body of the zygomatic bone. Ground electrodes will be placed on the respective mastoid process. EMG activity will be recorded at rest and maximal voluntary contraction. Time to fatigue will be recorded as time (in seconds) during which the muscles on both sides were able to perform maximum contraction until pain due to fatigue was first perceived by the patient.
Time frame
Baseline , after1 and 3 months of PBMTOther 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.
Time frame
6 months and 1 year after PBMTSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dr. Shalini Gupta
Lead sponsor
All India Institute of Medical Sciences
Sponsor institution
Source ClinicalTrials.gov