Effect of Laser photobiomodulation to improve mouth opening in precancerous lesion like Oral Submucous Fibrosis

A comparative evaluation of the adjunctive effect of photobiomodulation therapy using diode laser of 940nm wavelength on clinical functional molecular characteristics and oral health quality of life in Moderate Oral submucous Fibrosis - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067705

Enrollment

315

Registered

2024-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M798- Other specified soft tissue disorders

Interventions

Intervention1: Photobiomodulation therapy given intraorally on bilateral buccal mucosa and extraorally (sham) with conventional non-invasive management.: All patients will receive conventional non-inv

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects with symptomatic bilateral Moderate OSMF = 18 years of age 2. Subjects who have had no medical, surgical or physical intervention for OSMF at least 3 months prior to participation in this study. 3. Subjects willing to participate in the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Maximal interincisal mouth opening (mm)Timepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care	—

Secondary

Measure	Time frame
Cheek Flexibility(mm)Timepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Maximal interincisal mouth opening (mm)Timepoint: During follow-up at 3,6 and 12 months after intervention;Molecular Parameters by ELISA (IL6,TNFa,TGFß, CTGF) pg/ng per mlTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Oral Health Quality of Life (OHIP-14 scores)Timepoint: aseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Right and left Masseter muscle EMG((µV) Time to fatigue(sec) Timepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;VAS scores for oral Burning SensationTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;VAS scores for oral PainTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care	—

Measure

Time frame

Cheek Flexibility(mm)Timepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Maximal interincisal mouth opening (mm)Timepoint: During follow-up at 3,6 and 12 months after intervention;Molecular Parameters by ELISA (IL6,TNFa,TGFß, CTGF) pg/ng per mlTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Oral Health Quality of Life (OHIP-14 scores)Timepoint: aseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;Right and left Masseter muscle EMG((µV) Time to fatigue(sec) Timepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;VAS scores for oral Burning SensationTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care;VAS scores for oral PainTimepoint: Baseline Day 0 and One month after active / sham laser photobiomodulation intervention with usual care

—

Countries

India

Contacts

Public ContactDr Saman Ishrat

All India Institute of Medical Sciences N Delhi

shalinigupta@hotmail.com9971904592

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026