Status:
WITHDRAWN
Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
Lead Sponsor:
Koite Health Oy
Collaborating Sponsors:
Hammaslääkärit Eteläranta 10
University of Helsinki
Conditions:
Osteolysis
Dental Implants
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 t...
Detailed Description
After a dental implant procedure, implant stability is crucial for the success of the implant. The initial stability of the implant is determined by various factors such as implant design, surgical te...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06041828
Start Date
December 1 2025
End Date
December 31 2025
Last Update
November 19 2024
Active Locations (1)
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1
Hammaslääkärit Eteläranta 10
Helsinki, Uusimaa, Finland, 00130