Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis

  • End date
    Nov 30, 2025
  • participants needed
  • sponsor
    Koite Health Oy
Updated on 7 October 2022
periodontal disease
chronic periodontitis
Accepts healthy volunteers


The study is a single site, randomized clinical trial designed to determine the efficacy of the Lumoral treatment in periodontitis patients.


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 photodynamic therapy. The device is used by swishing a mouth rinse, strongly adhering to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple use light applicator. The antibacterial efficacy far exceeds chlorhexidine, without side effects in long-term use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

This early-stage study is designed to determine the efficacy of the Lumoral method in periodontitis patients. 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.

Condition Periodontitis
Treatment Lumoral treatment -device and Lumorinse tablets
Clinical Study IdentifierNCT05278416
SponsorKoite Health Oy
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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