Antibacterial Photodynamic Therapy in the Management of Peri-implantitis

NCT06017817 · tracked via the Priya Life Science Sweden tracker

Sponsor

Koite Health Oy

Phase

Not applicable

Started

2024-05-13

Last updated

2026-08-07

Condition(s) studied

Peri-ImplantitisPlaque, Dental

Investigational drug(s) / intervention(s)

Lumoral TreatmentStandard oral hygiene instructionsScaling and root planing (SRPsurgical anti-infective peri-implantitis treatment

Lumoral Treatment: Anti-infective photodynamic therapy for plaque-induced oral conditions

Standard oral hygiene instructions: Standard oral hygiene instructions for electric toothbrushing, interdental brush, and dental floss use

Scaling and root planing (SRP: non-surgical anti-infective treatment by scaling and root planing

surgical anti-infective peri-implantitis treatment: surgical anti-infective peri-implantitis treatment

Study summary

This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis. Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues, thus impacting osseointegration.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * PPD ≥6 mm and marginal bone loss \>3 mm * Dental implants collected and clinically characterized according to Lähteenmäki et al. CEDR-22 * Agreement to participate in the study and to sign a written consent form * Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: * Presence of any physical limitation or restriction that might restrict Lumoral use * Unwilling to participate in the study * Pregnancy or lactation * Active smoking * Medicated diabetes mellitus (DM) * Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of peri-implantitis * Use of antibiotics and doxycycline, chlorhexidine, and bisphosphonates, within 4 weeks week prior to study participation * Peri-implant and periodontal treatment within 3 months prior to study participation * Removable major prosthesis or major orthodontic appliance

Primary outcome measure(s)

Bleeding on probing (BOP) — 6 months
Change in the inflammatory parameter BOP. A full-mouth assessment at six sites per tooth: * 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 reported as the percentage (%) of sites with positive findings * Calculation formula: number of bleeding sites/ 6 times number of teeth

Trial sites (1)

Facility	City	Region	Status
Södertandläkarna AB	Stockholm	Sweden	Recruiting

Other trials for the same condition

Air-polishing in the Treatment of Peri-implantitis Enrolling by invitation

Transcriptome, Proteome and Microbiome Profile in Periodontal and Peri-implant Diseases Recruiting

Peri-implantitis - Reconstructive Surgical Therapy Active, not recruiting

Long-term Surgical Treatment Outcome of Peri-implantitis Lesions Recruiting

20-25 Year Follow-Up on Regenerative Bone Procedures for Peri-Implantitis Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06017817 on ClinicalTrials.gov ↗ ← All trials in Sweden