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

NCT06041828 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-19

No results posted yet for this study

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.

Conditions

  • Osteolysis
  • Dental Implants

Interventions

DEVICE

Lumoral Treatment

Photodynamic antibacterial dual-light device with a marker substance

OTHER

Standard oral hygiene

Standard oral hygiene instructions

Sponsors & Collaborators

  • Hammaslääkärit Eteläranta 10

    collaborator UNKNOWN

  • University of Helsinki

    collaborator OTHER

  • Koite Health Oy

    lead INDUSTRY

Principal Investigators

  • Timo Sorsa, Professor · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2025-12-01
Completion
2025-12-31

Countries

  • Finland

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 NCT06041828 on ClinicalTrials.gov