Clinical trial NCT05425784: Home Use of Dual-light Photodynamic Therapy for 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: Periodontal Diseases
Periodontitis
Plaque, Dental
Plaque Induced Gingivitis
Keywords: Lumoral
Lumorinse
Plaque
Periodontitis
Plaque control
aPDT
aMMP-8
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: University of Oulu
First posted: 2022-06-21
Enrollment: 41
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: 90 participants are randomized into two arms: the Lumoral-treatment arm and Control arm.
Primary purpose: TREATMENT

Brief summary: This early-stage research is designed to determine the efficacy of the Lumoral method in chronic 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: Periodontitis is a chronic inflammatory disease leading to a progressive loss of the tooth-supporting apparatus. The disease is strongly associated with deranged biodiversity patterns in dental plaque.

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. The antibacterial efficacy far exceeds chlorhexidine, without side effects in a longterm use. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Ninety (90) stage I-III periodontitis patients are randomized to Lumoral treatment group or control group. Both groups shall receive mechanical plaque control by scaling and root planning (SRP) and standard oral hygiene instructions for electric toothbrush, interdental brush, and dental floss use. All the patients shall be assessed for the clinical periodontitis status. These assessment and analyses shall be performed at baseline, at 3 months and at 6 months after the treatment.

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, including implants
* Agreement to participate in the study and to sign a written consent form
* Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

* Presence of major physical limitation or restriction that prohibit the hygiene procedures used in the study protocol
* Removable major prosthesis or major orthodontic appliance
* Pregnancy or lactation
* Use of antibiotics within 2 weeks prior the study
* A need for immediate antimicrobial treatment for periodontitis

Primary outcomes:
measure: Reduction in dental inflammation
timeFrame: 3 months
measure: Reduction in dental inflammation
timeFrame: 6 months
measure: Stabilization of the periodontal disease
timeFrame: 3 months
measure: Stabilization of the periodontal disease
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in aMMP-8 measurement
timeFrame: 3 months
measure: Reduction in aMMP-8 measurement
timeFrame: 6 months
measure: Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
timeFrame: 3 months
measure: Improvement in probing pocket depth (PPD) reflecting the clinical periodontitis status
timeFrame: 6 months
measure: Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
timeFrame: 3 months
measure: Improvement in clinical attachment level (CAL) reflecting the clinical periodontitis status
timeFrame: 6 months
measure: Change in periodontal microbiological pathogens.
timeFrame: 3 months
measure: Change in periodontal microbiological pathogens.
timeFrame: 6 months
measure: Improvement in oral-related quality of life.
timeFrame: 3 months
measure: Improvement in oral-related quality of life.
timeFrame: 6 months
Other outcomes:
Locations:
city: Kemi
country: Finland
facility: Mehiläinen Länsi-Pohja Central Hospital
state: Lappi
city: Oulu
country: Finland
facility: Hammas Hohde Oy
state: Oulun Lääni
city: Rovaniemi
country: Finland
facility: City of Rovaniemi Health Cervices, Oral Health
Study officials:
affiliation: Chief Medical Officer
name: Tommi Pätilä, Docent
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: PRINCIPAL_INVESTIGATOR
References: