Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

NCT05401201 | Completed

• 1 other identifier: OLP-01TRE
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).

Conditions

Oral Lichen Planus; Dental Plaque; Oral Bacterial Infection

Keywords

Lumoral; Lumorinse; Plaque; Oral Lichen Planus; aMMP-8; aPDT; Pain score (VAS)

Outcome Measures

Primary Outcomes (1)

• Pain score symptom diary (based on Visual Analogue Scale - VAS)

  Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: 1. '365 Average pain score' (VAS) is determined by calculating the average of the pain scores marked in the diary during the total surveillance period of one year; 2. '52 Average pain score' (VAS) is determined by calculating the average of the pain scores of calendar weeks during the total surveillance period of one year; 3. 'Positive 52 Average pain score' (VAS) is determined by including the '52 Average pain scores' of those calendar weeks, which have VAS average over 2.

  12 months

Secondary Outcomes (14)

• aMMP-8

  12 Months

• Visible plaque index (VPI)

  12 Months

• Bleeding on probing index (BOP)

  12 Months

• Escudier Index (EI)

  12 Months

• Visual Analogue Scale - VAS

  12 Months

Study Arms (2)

Study group

EXPERIMENTAL

Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.

Device: Lumoral treatment; Other: Standard oral hygiene self care

Control group

ACTIVE COMPARATOR

Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.

Other: Standard oral hygiene self care

Interventions

Lumoral treatment DEVICE

The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.

Also known as: Lumorinse mouth rinse

Study group

Standard oral hygiene self care OTHER

Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.

Also known as: Sonic toothbrush provided

Control group; Study group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
• Able to provide a written consent
• Willing and able to complete questionnaires
• Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

You may not qualify if:

• Lichenoid lesions suspected to be induced by contact allergy or drugs
• Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
• Pregnant or lactating
• Photosensitivity
• Use of antibiotics within 2 weeks prior the study

Sponsors & Collaborators

• Koite Health Oy: lead
• Wellbeing Services County of Pirkanmaa: collaborator
• Tampere University Hospital: collaborator
• Tampere University: collaborator
• University of Helsinki: collaborator

Study Sites (2)

Tampere University Hospital, Oral and maxillofacial diseases

Tampere, Pirkanmaa, 33520, Finland

Location

Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care

Tampere, Pirkanmaa, 33520, Finland

Location

Related Links

• Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review
• Al-Hashimi I, Schifter M, Lockhart PB, et al., (2007) Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations
• Akram Z, Javed F, Hosein M, et al., (2018) Photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review.
• Arduino PG, Broccoletti R, Sciannameo V, Scully C. (2017) A practical clinical recording system for cases of desquamative gingivitis
• Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. (2016) Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology
• Escudier M, Ahmed N, Shirlaw P, et al., (2007) A scoring system for mucosal disease severity with special reference to oral lichen planus.
• He Y, Deng J, Zhao Y, Tao H et al., (2020) Efficacy evaluation of photodynamic therapy for oral lichen planus: a systematic review and meta-analysis.
• Levine JI. Medications that increase photosensititivity.
• Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation.
• Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
• Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus
• Piboonniyom SO, Treister N, Pitiphat W, Woo SB. (2005) Scoring system for monitoring oral lichenoid lesions: a preliminary study.
• Slade GD (1997) Derivation and validation of a short-form oral health impact profile
• Spitzer RL, Kroenke K, Williams JBW, Löwe B (2006) A brief measure for assessing generalized anxiety disorder: the GAD-7
• Von Korff M, Ormel J, Keefe FJ, Dworkin SF (1992) Grading the severity of chronic pain
• NICE Guidance IPG615. Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy. Interventional procedures guidance \[IPG615\]. Published: 23 May 2018.

MeSH Terms

Conditions

Lichen Planus, Oral; Dental Plaque; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Dental Deposits; Tooth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tommi Pätilä, Docent

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A sealed envelope system shall be used for randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: February 24, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 13, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)