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

NCT05825742 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-21

No results posted yet for this study

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. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Conditions

  • Orthodontic Appliance Complication
  • Plaque, Dental
  • Gingival Inflammation

Interventions

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.

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Borgska Villans Specialisttandvård

    collaborator UNKNOWN

  • Koite Health Oy

    lead INDUSTRY

Principal Investigators

  • Ann-Marie Roos Jansåker, Professor · Borgska Villans Specialisttandvård

  • Tommi Pätilä, Docent · Koite Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-05
Primary Completion
2025-01-20
Completion
2025-03-05

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825742 on ClinicalTrials.gov