Clinical trial NCT05361590: Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health
Official title: Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Plaque, Dental
Plaque Induced Gingivitis
Keywords: Lumoral
Lumorinse
Plaque
Periodontitis
Plaque control
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: Tampere University
name: University of Helsinki
First posted: 2022-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 20 participants in the treatment (Lumoral) group and 20 participants in the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This early-stage study is designed to determine the efficacy of the CE-approved, antibacterial, dual-light Lumoral method in periodontitis patients. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Detailed description: Dental plaque triggers changes in gingival health, which results in slight swelling and bleeding from the gingival margin and causes gingivitis. Supragingival dental biofilm control can be achieved by mechanical and chemical means. Toothbrushing is effective in reducing levels of dental plaque (van der Weijden \& Slot 2015). It removes plaque from flat, accessible surfaces but is less effective at the gingival margins and in approximal areas, where the accumulation of residual plaque encourages gingivitis and deterioration of periodontal health. Effective toothbrushing is also depending on a number of factors, e.g., age, knowledge, manual dexterity and motivation. Oral hygiene instructions and patient motivation in oral hygiene practices should be an integral part of the patient management during all stages of periodontal treatment (Tonetti et al., 2015). Oral health practice of individuals affects their gingival and periodontal health.

The Lumoral 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, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. 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 the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Forty (40) patients are randomized to the Lumoral treatment group or the control group. Both groups shall receive standard oral hygiene instructions for sonic toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontal status including visible plaque index (VPI), bleeding on probing (BOP) and probing pocket depth (PPD). In addition, aMMP-8 mouth rinse test and microbiological analysis of gingival pockets will be performed. Digital photographs after staining will be taken. These analyses shall be performed at baseline and at 4 weeks after the treatment.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Agreement to participate in the study and to sign a written consent form

Exclusion Criteria:

* Presence of any physical limitation or restriction that might restrict Lumoral use
* Pregnancy or lactation

Primary outcomes:
measure: BoP
timeFrame: 4 weeks
Secondary outcomes:
measure: Microbiological pathogens
timeFrame: 4 weeks
measure: aMMP-8
timeFrame: 4 weeks
measure: VPI
timeFrame: 4 weeks
measure: PPD
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
state: Pirkanmaa
Study officials:
affiliation: Head of Research
name: Tommi Pätilä, Docent
role: STUDY_DIRECTOR
References: