Clinical trial NCT05278416: Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis
Official title: Regular Home Use of Dual-light Photodynamic Therapy in the Management of Chronic Periodontitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Lumoral
Lumorinse
Periodontitis
Anti-bacterial photodynamic therapy
aPDT
Plaque
aMMP-8
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
First posted: 2022-03-14
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Bleeding on Probing (BOP)
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Attachment Level (CAL)
timeFrame: 6 months
measure: Periodontal Pocket Depth (PPD)
timeFrame: 6 months
measure: Device-related adverse events
timeFrame: 6 months
measure: Inflammation marker aMMP-8 measurement
timeFrame: 6 months
measure: Visual Plaque Index (VPI)
timeFrame: 6 months
measure: OHIP-14
timeFrame: 6 months
measure: Patient-related objective: PCS questionnaire
timeFrame: 6 months
measure: Patient-related objective: OSCA questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Metropolia University of applied sciences
Study officials:
affiliation: Univeristy of Helsinki
name: Timo Sorsa, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Koite Health
name: Tommi Pätilä, Docent
role: STUDY_DIRECTOR
References: