Status:
COMPLETED
Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
Lead Sponsor:
Koite Health Oy
Collaborating Sponsors:
University of Helsinki
Conditions:
Periodontitis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.
Detailed Description
Lumoral treatment is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial pho...
Eligibility Criteria
Inclusion
- Periodontal disease stage I-III, according to criteria the American Academy of Periodontology (AAP) with at least 2 mm interdental CAL in the site of greatest loss
- Age of 18-85 years
- Presence of \> 20 teeth
- Agreement to participate in the study and to sign a written consent form
Exclusion
- Untreated/uncontrollable diabetes mellitus (DM) with HbA1c \>7%, and HbA1c \> 8 if insulin treated DM
- Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
- Use of medicine that would affect the periodontal tissue within the last 6 months (antibiotics, anti-inflammatories, anticonvulsants, immunosuppressants, or calcium channel blockers, including doxycycline, bisphosphonates and chlorhexidine)
- Periodontal treatment during the previous 3 months
- Allergic to the photosensitizer
- Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
- Removable major prosthesis or major orthodontic appliance
- Active smoking, or habitual use of smokeless tobacco products
- Pregnancy or lactation
- A need for a hopeless teeth extraction, or open cavities in need for immediate endodontic treatment
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2025
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05278416
Start Date
February 8 2022
End Date
April 29 2025
Last Update
August 11 2025
Active Locations (1)
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1
Metropolia University of applied sciences
Helsinki, Finland