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Orthodontic Appliance ComplicationNCT05825742

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

A study testing Lumoral Treatment and Standard oral health instructions in people with Orthodontic Appliance Complication and Plaque, Dental, run by Koite Health Oy at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 15 to 18 years
What is being tested?
Lumoral Treatment and Standard oral health instructions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
5 Sep 2023to 5 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Borgska Villans Specialisttandvård

    Lund, 22355

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Lumoral Treatment, Standard oral health instructions
Medical subject headings
Dental Plaque, Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumoral TreatmentDevice

    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.

  • Standard oral health instructionsOther

    Subjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.

Study groups in NCT05825742
Study groupRoleWhat they receive
Lumoral Treatment (Study group)ExperimentalSubjects 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.
Receives: Device: Lumoral Treatment; Other: Standard oral health instructions
Standard of care (Control group)OtherSubjects will receive the latest standard oral hygiene instructions according to the Swedish dental association's guidelines.
Receives: Other: Standard oral health instructions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Visible plaque index (VPI)

    • 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

    Measured: 12 weeks

Secondary outcomes (3)

  1. Change in Bleeding on probing (BOP)

    • 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

    Measured: 12 weeks

  2. Change in Orthodontic plaque index (OPI)

    • 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)

    Measured: 12 weeks

  3. Change in periodontal microbiological flora

    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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2023
  2. Study start5 Sep 2023
  3. Primary completion20 Jan 2025
  4. Study completion5 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants in two groups (Study group and Control group) shall receive instructions for standard oral hygiene. The same assessments are done for participants in both groups, and within the same time periods. The Study group will also be using the Lumoral Treatment device.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05825742
Sponsor's protocol ID
CLEAN-BRACKET
Status last verified
Jan 2026
First submitted
11 Apr 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Erbe C, Klees V, Braunbeck F, Ferrari-Peron P, Ccahuana-Vasquez RA, Timm H, Grender J, Cunningham P, Adam R, Wehrbein H. Comparative assessment of plaque removal and motivation between a manual toothbrush and an interactive power toothbrush in adolescents with fixed orthodontic appliances: A single-center, examiner-blind randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Apr;155(4):462-472. doi: 10.1016/j.ajodo.2018.12.013.

    PubMed 30935601

  • Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.

    PubMed 34063662

  • Verrusio C, Iorio-Siciliano V, Blasi A, Leuci S, Adamo D, Nicolo M. The effect of orthodontic treatment on periodontal tissue inflammation: A systematic review. Quintessence Int. 2018;49(1):69-77. doi: 10.3290/j.qi.a39225.

    PubMed 29114647

  • Walsh LJ, Healey DL. Prevention and caries risk management in teenage and orthodontic patients. Aust Dent J. 2019 Jun;64 Suppl 1:S37-S45. doi: 10.1111/adj.12671.

    PubMed 31144319

Questions about this trial

What is this clinical trial studying?

A study testing Lumoral Treatment and Standard oral health instructions in people with Orthodontic Appliance Complication and Plaque, Dental, run by Koite Health Oy at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visible plaque index (VPI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05825742, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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