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LASER therapy for Oral submucous fibrosis- a condition caused by betel-nut chewing

EVALUATION OF LASER PHOTOBIOSTIMULATION THERAPY IN MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS: A PROSPECTIVE INTERVENTIONAL STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/08/044534
Enrollment
12
Registered
2022-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: LOW LEVEL LASER THERAPY/PHOTOBIOSTIMULATION: Diode laser unit (Lite Medics 980nm) Each patient will undergo biweekly treatment visits starting at Day 0, 3, 7 and 15
each visit will consist of three cycles of laser photobiostimulation, each cycle for 15 Seconds with a gap of about 30 seconds between each cycle, for a total application time of about three minutes.

Sponsors

DR D Y PATIL DENTAL COLLEGE AND HOSPITAL DR D Y PATIL VIDYAPEETH PUNE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 10 years and above irrespective of their gender clinically diagnosed with OSMF with functional staging of M2 and M3 (More C et al 2011) who are willing to give their consent or their guardianââ?¬•s/parentââ?¬•s consent to be a part of the study

Exclusion criteria

Exclusion criteria: 1. Patients who are undergoing/have undergone chemotherapy, radiotherapy or any mucosal surgical procedure 2. Patients having other mucosal lesions, such as oral leukoplakia, oral lichen planus, oro-pharyngeal cancer 3. Patient who wishes to discontinue to be a part of the study during the treatment

Design outcomes

Primary

MeasureTime frame
1. To determine the clinical improvement in M2 (Functional staging) OSMF with LASER photobiostimulation using changes in interincisal opening and VAS score for burning sensation 2. To determine the clinical improvement in M3 (Functional staging) OSMF with LASER photobiostimulation using changes in interincisal opening and VAS score for burning sensationTimepoint: DAY 0, 3, 7, 15

Secondary

MeasureTime frame
To compare the treatment outcome in M2 and M3 functional stages of OSMFTimepoint: DAY 0, 3, 7, 15

Countries

India

Contacts

Public ContactDR SUNIL S MISHRA

DR D Y PATIL DENTAL COLLEGE AND HOSPITAL, DR D Y PATIL VIDYAPEETH, PIMPRI, PUNE

sunil.mishra@dpu.edu.in9890515247

Outcome results

None listed

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