WithdrawnNot Applicable

Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery

Stopped: The study has been temporarily halted due to time constraints at the study site.

Finland0Started 2025-12

Plain-language summary

The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Subjects will be randomized into two groups (20 + 20 subjects) and all will be given individual guidance on maintaining good oral hygiene. The participants in the study group will also be given Lumoral appliances with instructions for use at home. The Lumoral device has been shown in previous studies to be safe to use and effective in eliminating harmful oral bacteria.

Who can participate

Age range18 Years – 85 Years

SexALL

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 ≥ 18 years * Generally healthy, * At least one new implant inserted * New implant inserted * Agreement to participate in the study with a written consent form signed Exclusion Criteria: * Uncontrolled diabetes mellitus (DM) * Active smoking * Any significant systemic disease * Immediate implantation after tooth extraction * Use of antibiotics within 4 weeks week prior study * Presence of any physical limitation or restriction that might restrict Lumoral use * Pregnancy or lactation * History of six months use of antimicrobials, bisphosphonates, or corticosteroids.

What they're measuring

Incidence of osteolysis around dental implants

Timeframe: 4 months

Trial details

NCT IDNCT06041828

SponsorKoite Health Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

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