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

April 15, 2024 updated by: Koite Health Oy

Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Topical Corticosteroid Treatment in Patients With Gingival Involvement of Oral Lichen Planus - a Randomized Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva.

Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

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.

All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started.

In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation.

Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Not yet recruiting
        • Tampere University Hospital, Oral and maxillofacial diseases
        • Contact:
        • Principal Investigator:
          • Anna Maria Heikkinen, Professor
        • Sub-Investigator:
          • Kati Ylä-Tuuhonen, DDS
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
        • Contact:
        • Principal Investigator:
          • Anna Maria Heikkinen, Professor
        • Sub-Investigator:
          • Kati Ylä-Tuuhonen, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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
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.
Other Names:
  • Lumorinse mouth rinse
Other: Standard oral hygiene self care
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.
Other Names:
  • Sonic toothbrush provided
Active Comparator: Control group
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
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.
Other Names:
  • Sonic toothbrush provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score symptom diary (based on Visual Analogue Scale - VAS)
Time Frame: 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
aMMP-8
Time Frame: 12 Months
Reduction in inflammation marker aMMP-8 measured by Periosafe®
12 Months
Visible plaque index (VPI)
Time Frame: 12 Months
Improvement in visible plaque index (VPI)
12 Months
Bleeding on probing index (BOP)
Time Frame: 12 Months
Improvement in the bleeding on probing index (BOP)
12 Months
Escudier Index (EI)
Time Frame: 12 Months
Improvement in OLP measured by the Escudier Index (EI)
12 Months
Oral Lichen Planus (OLP) relapse
Time Frame: 12 Months
Improvement in OLP relapse rate measured by a decreased need for additional/ repeated treatment with corticosteroid treatment, tacrolimus, or other anti-inflammatory treatment
12 Months
Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)
Time Frame: 12 Months
Improvement in psychosocial factors assessed by the graded chronic pain scale (GCPS) questionnaire. Grading is based on answering a ten-scale questionnaire from 0, 'no pain' to 10, 'worst possible pain'.
12 Months
Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)
Time Frame: 12 Months
Improvement in psychosocial factors assessed by the oral health impact profile-14 (OHIP-14) questionnaire. The OHIP-14 is a questionnaire that measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
12 Months
Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)
Time Frame: 12 Months
Improvement in psychosocial factors assessed by the generalized anxiety disorder (GAD-7) questionnaires. Grading is based on answering a four-scale questionnaire from 0, 'never' to 3, 'almost daily'.
12 Months
Oral candidosis
Time Frame: 12 Months
Reduction in number of subjects with oral candidosis during the treatment
12 Months
Visual Analogue Scale - VAS
Time Frame: 12 Months

Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0.

The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
12 Months
Visual Analogue Scale - VAS
Time Frame: 6 Months

Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0.

The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
6 Months
Visual Analogue Scale - VAS
Time Frame: 3 Months

Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0.

The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
3 Months
Use of corticosteroid treatment
Time Frame: 6 Months
Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
6 Months
Desquamative gingivitis clinical score (DGCS)
Time Frame: 12 Months
Improvement in OLP measured by the Desquamative Gingivitis Clinical Score (DGCS) by 20 %. The DGCS is a scoring system specifically designed to score the gingival lesions of oral lichen planus. Scoring: 0 = no detectable lesions present; 1 = white lesion; 2 = mild erythema (< 3 mm from gingival margins); 3 = bulla or marked erythema (> 3 mm from gingival margins); 4 = erosion or ulcer
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koite Health Oy

Collaborators

University of Helsinki
Tampere University
Tampere University Hospital
Wellbeing Services County of Pirkanmaa

Investigators

  • Study Director: Tommi Pätilä, Docent, Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

May 27, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLP-01TRE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will only be administered by the researchers that are listed in the CIP.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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