Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons

NCT06576063 | Recruiting

• 1 other identifier: LumoKoti2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

On average, the dental condition of elderly people is poor due to various reasons. The importance of oral health maintenance of the ageing population has been recognized by the World Health Organization (WHO), as oral health plays a key role in reaching the global goal of the "Decade of Healthy Ageing 2021-2030". New measures for maintaining good oral health are welcome. The use of antibacterial photodynamic therapy (aPDT) and antibacterial blue light (aBL) has been studied and found to reduce the amount of plaque in the mouth. The Lumoral device is a CE-marked home medical device combining aPDT and aBL, and it is effective in reducing the development of plaque and harmful bacteria in the plaque. The device has also been shown to be easy and safe to use. In this study, a combination of regular dental appointments with the importance of enhanced dental self-care, will be tested as one regional solution for reaching the global goal set by WHO.

Conditions

Dental Plaque; Bleeding of Subgingival Space; Oral Complication

Keywords

Lumoral; Preventive oral care; Antibacterial photodynamic therapy (aBPT); aMMP-8; Plaque control; Oral hygiene

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BOP)

  Change in the inflammatory parameter 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.

  9 months

Secondary Outcomes (7)

• Plaque index (RMNPI)

  9 months

• Periodontal Pocket Depth (PPD)

  9 months

• Active matrix metalloproteinase 8 (aMMP-8)

  9 months

• Oral Bacterial flora

  9 months

• Dryness of Mouth (DOM)

  9 months

Study Arms (2)

Study group

EXPERIMENTAL

Standard oral hygiene methods and adjuvant use of Lumoral Treatment device

Device: Lumoral Treatment; Behavioral: Standard oral hygiene methods

Control group

ACTIVE COMPARATOR

Standard oral hygiene methods

Behavioral: Standard oral hygiene methods

Interventions

Lumoral Treatment DEVICE

Home-use of photodynamic antibacterial dual-light device, used with a marker substance (indocyanine green)

Study group

Standard oral hygiene methods BEHAVIORAL

Best available standard oral self-care hygiene methods performed at home and instructed by oral healthcare professionals, supported by professional cleaning at the oral healthcare clinic

Control group; Study group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• An elderly (age ≥ 65 years) person living at home or at care home, with a possibility to regular dental care appointments
• Ability to understand and sign the informed consent
• At least 10 teeth in the mouth, including implants
• Ability to understand and follow the study protocol, including tooth brushing and following the instructions for the use of Lumoral Treatment, based on the assessment of the investigator

You may not qualify if:

• Uncontrolled diabetes mellitus (DM)
• Severe dementia or other similar conditions that may restrict understanding of the study information and protocol
• Presence of any physical limitation or restriction that might restrict Lumoral use
• Active smoking and use of other tobacco products
• Use of antibiotics within 4 weeks week prior study
• Oral thrush
• Known sensitivity to near-infrared or antibacterial blue light.

Sponsors & Collaborators

• Koite Health Oy: lead
• University of Helsinki: collaborator

Study Sites (3)

SuperSuu

Loviisa, Uusimaa, 07900, Finland

RECRUITING

SuperSuu

Sipoo, Uusimaa, 04130, Finland

RECRUITING

KotiHammas

Vantaa, Uusimaa, 01600, Finland

RECRUITING

Related Publications (7)

• Cugini M, Thompson M, Warren PR. Correlations between two plaque indices in assessment of toothbrush effectiveness. J Contemp Dent Pract. 2006 Nov 1;7(5):1-9.

  PMID: 17091134 BACKGROUND

• Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. 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. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.

  PMID: 35723308 BACKGROUND

• 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.

  PMID: 34063662 BACKGROUND

• Saarela RKT, Hiltunen K, Mantyla P, Pitkala KH. Changes in Institutionalized Older People's Dentition Status in Helsinki, 2003-2017. J Am Geriatr Soc. 2020 Jan;68(1):221-223. doi: 10.1111/jgs.16230. Epub 2019 Oct 26. No abstract available.

  PMID: 31654530 BACKGROUND

• Saarela RKT, Hiltunen K, Kautiainen H, Roitto HM, Mantyla P, Pitkala KH. Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med. 2022 Feb;13(1):213-220. doi: 10.1007/s41999-021-00547-8. Epub 2021 Jul 27.

  PMID: 34313976 BACKGROUND

• Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.

  PMID: 36135158 BACKGROUND

• Suominen AL, Varsio S, Helminen S, Nordblad A, Lahti S, Knuuttila M. Dental and periodontal health in Finnish adults in 2000 and 2011. Acta Odontol Scand. 2018 Jul;76(5):305-313. doi: 10.1080/00016357.2018.1451653. Epub 2018 Mar 16.

  PMID: 29546776 BACKGROUND

Related Links

• Berger, V., Bour, L., Carter, K. et al. A roadmap to using randomization in clinical trials. BMC Med Res Methodol 21, 168 (2021)
• Chan, AKY., Chu, CH., Ogawa, H., Hsiang-Hua Lai, E. Improving oral health of older adults for healthy ageing, Journal of Dental Sciences. (2023). ISSN 1991-7902
• Dodds, M., Roland, S., Edgar, M. et al. Saliva A review of its role in maintaining oral health and preventing dental disease. BDJ Team 2, 15123 (2015).

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Timo Sorsa, Professor

  University of Helsinki

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikko Kylmänen, Master of Health Care

CONTACT

+358407245934; mikko.kylmanen@koitehealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized clinical study on a medical device.

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)