Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment

January 20, 2026 updated by: Koite Health Oy

Efficacy of Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment - Randomized, Controlled Clinical Study

This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis.

The 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. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Sweden
      • Lund, Sweden, 22355
        • Borgska Villans Specialisttandvård

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age of 15-18 years old
  • starting fixed orthodontic treatment
  • good oral hygiene according to the dentist's assessment
  • absence of periodontal disease and lack of oral lesion
  • signed a written consent form, including information to caregivers.

Exclusion Criteria:

  • any chronic diseases
  • medications that could influence the study (according to the dentists' assessment)
  • active caries or a supposed high risk of caries
  • gingivitis (bleeding on probing >10%)
  • use of antiseptic mouthwashes
  • smoking
  • use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
  • unable to cooperate with the protocol.
  • pregnancy or lactation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lumoral Treatment (Study group)

Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.

Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Device: Lumoral Treatment
Subjects will receive detailed instructions for the use of Lumoral treatment -device. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day for two months and to keep a diary.
Other: Standard oral health instructions
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Other: Standard of care (Control group)
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Other: Standard oral health instructions
Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visible plaque index (VPI)
Time Frame: 12 weeks
  • A full-mouth assessment, measured at six sites per tooth.
  • Dichotomous scoring to each site of the tooth as plaque "1 present" and "0 absent"
  • VPI is reported as the percentage (%) of sites with plaque.
  • Calculation formula: number of sites with plaque/ 6 times number of teeth
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bleeding on probing (BOP)
Time Frame: 12 weeks
  • A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual)
  • Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus.
  • Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent"
  • BOP is reported as the percentage (%) of sites with positive findings.
  • Calculation formula: number of bleeding sites/ 6 times number of teeth
12 weeks
Change in Orthodontic plaque index (OPI)
Time Frame: 12 weeks
  • The OPI indicates the presence of plaque around the multibracket appliance after staining the teeth with a plaque-disclosing solution.
  • Using the data from the digital photographs, selected six (6) index teeth that bear an adhesively bonded bracket will be evaluated.

  • The status is indicated as a score from 0 to 4. The degree of plaque accumulation on each aspect of the bracket base and the condition of the adjacent marginal gingivae are assessed: 0 = No plaque deposits on the tooth surfaces surrounding the bracket base

    1. = Plaque deposits on one tooth surface at the bracket base
    2. = Plaque deposits on two tooth surfaces at the bracket base
    3. = Plaque deposits on three tooth surfaces at the bracket base
    4. = Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)
12 weeks
Change in periodontal microbiological flora
Time Frame: 12 weeks

Microbiological sampling and analysis:

  • Quantification of periodontopathic bacteria by 16S rRNA sequencing analysis.
  • Microbiological samples can be collected using Iso Taper Paper Points, size-20 (VDW GmbH) from the plaque on the surface of the teeth, using a curette if needed. The paper points can be placed into sterile, small-aliquot containers, and immediately stored at -20°C until analysis.
  • 16S rRNA sequencing can be performed at a qualified laboratory assigned by the study sponsor
12 weeks

Collaborators and Investigators

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

Sponsor

Koite Health Oy

Collaborators

Helsinki University Central Hospital
University of Helsinki
Borgska Villans Specialisttandvård

Investigators

  • Principal Investigator: Ann-Marie Roos Jansåker, Professor, Borgska Villans Specialisttandvård
  • Study Director: Tommi Pätilä, Docent, Koite Health

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.

General Publications

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)

September 5, 2023

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEAN-BRACKET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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