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

NCT ID: NCT05278416

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2025-04-29

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 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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lumoral treatment -device and Lumorinse tablets

Subjects will receive detailed instructions for the use of Lumoral treatment -device and Lumorinse tablets. Subjects will be instructed to use the Lumoral treatment -device and follow the protocol once a day.

Group Type: ACTIVE_COMPARATOR

Lumoral treatment -device and Lumorinse tablets

Intervention Type: DEVICE

Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.

Standard of Care

Subjects will receive oral hygiene instructions for the sonic toothbrushing and the use of interdental cleaning devices. They will not receive an additional intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lumoral treatment -device and Lumorinse tablets

Subjects will use Lumoral treatment -device and Lumorinse tablets daily as per protocol.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Metropolia University of Applied Sciences

OTHER

Sponsor Role: collaborator

Koite Health Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timo Sorsa, Professor

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Helsinki

Tommi Pätilä, Docent

Role: STUDY_DIRECTOR

Koite Health

Locations

Metropolia University of applied sciences

Helsinki, , Finland

Countries

Finland

Other Identifiers

KHE2021Metro (HOPE-CP)

Identifier Type: -

Identifier Source: org_study_id