Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

Periodontitis Chronic Generalized Severe Clinical Trial

Official title:

Regular Home-use of Dual-light Photodynamic Therapy in the Management of Chronic Stage III-IV Periodontitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698823
• Other study ID #: LumoKaunas2023
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Koite Health Oy
• Contact: Mikko Kylmänen, Bachelor
• Phone: +358407245934
• Email: mikko.kylmanen[@]koitehealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis
• Periodontitis Chronic Generalized Moderate
• Periodontitis Chronic Generalized Severe

Intervention

Device:
• Lumoral Treatment
The Lumoral treatment -device is a CE-marked antibacterial home-use device for the treatment and prevention of oral diseases caused by bacteria. It is used in combination with a CE-marked mouth rinse called Lumorinse.

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Department of Dental and Oral Pathology	Kaunas

Sponsors (3)

Lead Sponsor	Collaborator
Koite Health Oy	Lithuanian University of Health Sciences, University of Helsinki

Country where clinical trial is conducted

Lithuania, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device-related adverse event	Absence of device-related serious adverse events or any patterns of device-related adverse events graded as moderate	6 months
Primary	Bleeding on probing (BOP)	Improvement in bleeding on probing (BOP); A full-mouth assessment at six sites per tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual, distolingual); Gingival bleeding is considered as positive if bleeding occurs within 15 seconds after gentle probing with a probe at the sulcus; Dichotomous scoring to each site of the tooth as bleeding "1 present" and "0 absent"; BOP is reported as the percentage (%) of sites with positive findings; Calculation formula: number of bleeding sites/ 6 times number of teeth	6 months
Secondary	Active matrix metalloproteinase 8 (aMMP-8)	Change in periodontal inflammation marker aMMP-8	6 months
Secondary	Visible plaque index (VPI)	Change in visible plaque index (VPI)	6 months
Secondary	Probing pocket depth (PPD)	Change in probing pocket depth (PPD)	6 months
Secondary	Clinical attachment level (CAL)	Change in clinical attachment level (CAL)	6 months
Secondary	Deep periodontal pockets (over 4 mm)	Change in the number of deep periodontal periodontal pockets (over 4 mm)	6 months
Secondary	Periodontal microbiological flora	Change in periodontal microbiological flora during the study period	6 months
Secondary	Additional visits	Number of additional visits due to periodontitis status between 2nd and 3rd follow-up visits	6 months
Secondary	OHIP-14	Patient related objectives: Oral-related quality of life measurement (OHIP-14) questionnaire	6 months

External Links

•   Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review. Laser Dent Sci 3, 147-153 (2019)
•   Gomes SC, Romagna R, Rossi V, Corvello PC, Melchiors-Angst PD. Supragingival treatment as an aid to reduce subgingival needs: a 450-day investigation Braz. oral res. 28 (1) 2014
•   Lähteenmäki H, Pätilä T, Räisänen IT, et al. (2022). Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease - A Pilot Study. Curr. Issues Mol. Biol. 44,1273-1283
•   Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.
•   Loos BG & Needleman I (2020) Endpoints of active periodontal therapy. J Clin Periodontol. 2020; 47: 61- 71.
•   Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation. PLoS ONE 15(5): e0232775
•   Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus. Antibiotics, 10 (10): 1240
•   Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67