CompletedNot Applicable

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

Sweden40 participantsStarted 2023-09-05

Plain-language 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.

Who can participate

Age range

15 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Visible plaque index (VPI)

Timeframe: 12 weeks

Trial details

NCT IDNCT05825742

SponsorKoite Health Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-20

View on ClinicalTrials.gov More Orthodontic Appliance Complication trials