Impact of Regular Home Use of Lumoral Dual-light Photodynamic Therapy on Plaque Control and Gingival Health

NCT ID: NCT05361590

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-11
• Study Completion Date: 2023-08-16

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.

Conditions

Periodontitis; Plaque, Dental; Plaque Induced Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Study group

Subjects in the study group will use the Lumoral device once a day according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.

Group Type: EXPERIMENTAL

Lumoral device

Intervention Type: DEVICE

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.

Control group

Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.

Group Type: ACTIVE_COMPARATOR

Lumoral device

Intervention Type: DEVICE

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.

Interventions

Lumoral device

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.

Intervention Type: DEVICE

Other Intervention Names

Lumorinse mouth rinse

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Koite Health Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tommi Pätilä, Docent

Role: STUDY_DIRECTOR

Head of Research

Locations

Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care

Tampere, Pirkanmaa, Finland

Countries

Finland

Related Links

https://doi.org/10.1007/s41547-019-00056-9

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

https://scirp.org/reference/referencespapers.aspx?referenceid=2467179

Chapple ILC, Mealey BL, Van Dyke TE et al., (2018). Periodontal health and gingival diseases and conditions on an intact and a reduced periodontium: Consensus report of workgroup 1 of the 2017 World Workshop on the Classification of Periodontal and Peri-

https://www.fda.gov/media/75892/download

Levine JI. Medications that increase photosensititivity. FDA document Dec 1990.

https://doi.org/10.1371/journal.pone.0232775

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.

https://researchportal.helsinki.fi/en/publications/repeated-home-applied-dual-light-antibacterial-photodynamic-thera

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

http://dx.doi.org/10.1016/j.parkreldis.2017.02.026

Pereira PAB, Aho VTE, Paulin L, et al., (2017) Oral and nasal microbiota in Parkinson's disease. Parkinsonism and Related Disorders 38: 61-67.

https://pubmed.ncbi.nlm.nih.gov/32383274/

Sanz M, Herrera D, Kebschull M, et al.; On behalf of the EFP Workshop Participants and Methodological Consultants. (2020) Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol., 47: 4- 60.

https://pubmed.ncbi.nlm.nih.gov/25639948/

Tonetti MS, Eickholz P, Loos BG et al., (2015). Principles in prevention of periodontal diseases: Consensus report of group 1 of the 11th European Workshop on Periodontology on effective prevention of periodontal and peri-implant diseases. Journal of

https://pubmed.ncbi.nlm.nih.gov/25597787/

Van der Weijden FA \& Slot DE (2015). Efficacy of homecare regimens for mechanical plaque removal in managing gingivitis: A metareview. Journal of Clinical Periodontology, 42(Suppl 16), S77-S91

https://doi.org/10.1590/S1806-83242014.50000004

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)

Other Identifiers

DPS-01

Identifier Type: -

Identifier Source: org_study_id