To check difference in laser and steroid therapy on Oral lichen planus patients .

Not yet recruiting

• Conditions: subjects having symptomatic oral lichenplanus; Other and unspecified lesions of oral mucosa,

• Registration Number: CTRI/2022/10/046519
• Lead Sponsor: Sakshi Batra

Brief Summary

The purpose of the study is to compare the effectiveness of photodynamic therapy (660nm) Vs. Triamcinolone acetonide 0.1% in symptomatic oral lichen planus patient and assessment of markers IL-1 beta,IL-6,TNF-alpha and MDA  in both groups before and after the treatment. 30 patients randomly selected in each group. Patients in control group given topical corticosteroid (0.1%), topical application 3 times daily with no food or fluid intake 1 hour after application for 1 month. Follow-up done every week and VAS and RAE scoring once a month and at baseline(i.e baseline,1 month, 2month, 3month). Patients of the experimental group will be treated with photobiomodulation with low-level diode laser equipment and along with the topical application of toludine blue on the lesion acting as a photosensitizer. Irradiated with 660nm diode laser with a continuous pulse,contact mode ,100mW for 60 sec on each cm2 i.e. 6j ,2 times a week for 1 month. blood and saliva sample collection done pre treatment and at 3 months of follow up.Comparative evaluation of VAS and RAE score done and ELISA test will be undertaken from the samples collected and stored for estimation of IL̵   1 beta ,IL-6 ,TNF-alpha and the thiobarbituric acid test for MDA estimation, from this comparative evaluation of change of these salivary and serum markers, will be done to know the comparative effectiveness of both treatments

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• i.Participants of both gender and age between 18 years to 60 years, will be diagnosed with symptomatic lesions of reticular, atrophic, and erosive oral lichen planus based on clinical, histopathological criteria by WHO.
• ii.Patients who give informed consent after explaining the treatment type will be included in the study.

Exclusion Criteria

• i.Patients with any other Potentially Malignant Oral Disorders (PMOD) will be excluded.
• ii.Pregnant females and breastfeeding mothers will be excluded.
• iii.Patients having photosensitivity will be excluded.
• iv.Patients with a history of corticosteroids, NSAIDs, or any other treatment in the last 30 days will be excluded.
• v.Patients with other systemic diseases or illnesses will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain and burning sensation	baseline,1 month,2nd month,3rd month

Secondary Outcome Measures

Name	Time	Method
size of the lesion	baseline,1month,2nd month,3rd month.

Trial Locations

Locations (1)

Unit of Oral Medicine and Radiology; 🇮🇳 Varanasi, UTTAR PRADESH, India

Unit of Oral Medicine and Radiology

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Sakshi Batra

Principal investigator

7275567124

drsakshioralmed@gmail.com