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RECRUITING
NCT06576063
NA

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

Sponsor: Koite Health Oy

View on ClinicalTrials.gov

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.

Official title: Effects of the Regular Use of Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons Living at Home or at Care Homes

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-01-02

Completion Date

2027-06

Last Updated

2025-08-07

Healthy Volunteers

Yes

Interventions

DEVICE

Lumoral Treatment

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

BEHAVIORAL

Standard oral hygiene methods

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

Locations (3)

SuperSuu

Loviisa, Uusimaa, Finland

SuperSuu

Sipoo, Uusimaa, Finland

KotiHammas

Vantaa, Uusimaa, Finland