Clinical trial NCT05698823: Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
Official title: Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis Chronic Generalized Moderate
Periodontitis Chronic Generalized Severe
Keywords: Lumoral
Lumorinse
Periodontitis
Anti-bacterial photodynamic therapy
aPDT
Plaque
aMMP-8
Photobiomodulation
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: Lithuanian University of Health Sciences
First posted: 2023-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to determine the efficacy of the Lumoral method in chronic periodontitis with a targeted group of stage III and IV periodontitis.

Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term.

In addition, the method might have a photobiomodulation effect on periodontal tissues.

Detailed description: The 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 (aPDT). The device is used by swishing a specially designed mouth rinse that strongly adheres to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator. Preliminary results have shown promising anti-inflammatory responses in addition to plaque reduction.

Eligibility criteria: Inclusion Criteria:

* Periodontal disease stage III-IV, according to criteria the American Academy of Periodontology (AAP) with at least 3 mm interdental clinical attachment level (CAL) in the site of greatest loss.
* ≥ 18 years old
* 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:

* Grade A or C periodontitis
* Presence of any physical limitation or restriction that might restrict Lumoral use
* Pregnancy or lactation
* Active smoking
* Medicated diabetes mellitus (DM)
* Any systemic disease (e.g., wound healing dysfunctions) that could alter the progression of periodontal disease
* Use of antibiotics within 4 weeks week prior study
* Periodontal treatment within 3 months prior study
* Removable major prosthesis or major orthodontic appliance
* 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: Active matrix metalloproteinase 8 (aMMP-8)
timeFrame: 6 months
measure: Visible plaque index (VPI)
timeFrame: 6 months
measure: Probing pocket depth (PPD)
timeFrame: 6 months
measure: Clinical attachment level (CAL)
timeFrame: 6 months
measure: Deep periodontal pockets (over 4 mm)
timeFrame: 6 months
measure: Periodontal microbiological flora
timeFrame: 6 months
measure: Additional visits
timeFrame: 6 months
measure: OHIP-14
timeFrame: 6 months
Other outcomes:
measure: Device-related adverse event
timeFrame: 6 months
Locations:
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology
Study officials:
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: STUDY_DIRECTOR
affiliation: Koite Health
name: Tommi Pätilä, Docent
role: STUDY_CHAIR
affiliation: Lithuanian University of Health Sciences
name: Ingrida Marija Pacauskiene, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of severe periodontitis in 1990-2010: a systematic review and meta-regression. J Dent Res. 2014 Nov;93(11):1045-53. doi: 10.1177/0022034514552491. Epub 2014 Sep 26.
citation: Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
citation: Lang NP, Suvan JE, Tonetti MS. Risk factor assessment tools for the prevention of periodontitis progression a systematic review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S59-70. doi: 10.1111/jcpe.12350.
citation: Nikinmaa S, Moilanen N, Sorsa T, Rantala J, Alapulli H, Kotiranta A, Auvinen P, Kankuri E, Meurman JH, Patila T. Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque. Dent J (Basel). 2021 May 3;9(5):52. doi: 10.3390/dj9050052.
citation: Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.