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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oral Lichen Planus Treatment

NCT05127083

Oral Lichen Planus

COMPLETED NA

Photobiomodulation in Oral Lichen Planus

NCT03320460

Lichen Planus, Oral Low-Level Light Therapy

UNKNOWN NA

Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy

NCT05973097

Oral Lichen Planus

RECRUITING NA

Tacrolimus Ointment in Oral Lichen Planus

NCT01544842

Oral Lichen Planus

TERMINATED NA

Evaluation of Diode Laser and Topical Steroid Therapy in the Treatment of Erosive Oral Lichen Planus

NCT05951361

Erosive Oral Lichen Planus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Lichen Planus Dental Plaque Oral Bacterial Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

A sealed envelope system shall be used for randomization.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Lumoral treatment

Intervention Type 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.

Standard oral hygiene self care

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Standard oral hygiene self care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Standard oral hygiene self care

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lumorinse mouth rinse Sonic toothbrush provided

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No