Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
NCT06576063

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

Led by Koite Health Oy · Updated on 2025-08-07

100

Participants Needed

3

Research Sites

125 weeks

Total Duration

On this page

Sponsors

K

Koite Health Oy

Lead Sponsor

U

University of Helsinki

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Elderly person aged 65 years or older living at home or in a care home with access to regular dental care appointments
  • Ability to understand and sign informed consent
  • Having at least 10 teeth in the mouth, including implants
  • Ability to understand and follow the study protocol, including tooth brushing and using the Lumoral Treatment, as assessed by the investigator
Not Eligible

You will not qualify if you...

  • Uncontrolled diabetes mellitus
  • Severe dementia or similar conditions limiting understanding of study information and protocol
  • Physical limitations restricting use of the Lumoral device
  • Current active smoking or use of other tobacco products
  • Use of antibiotics within 4 weeks prior to the study
  • Presence of oral thrush
  • Known sensitivity to near-infrared or antibacterial blue light

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

SuperSuu

Loviisa, Uusimaa, Finland, 07900

Actively Recruiting

2

SuperSuu

Sipoo, Uusimaa, Finland, 04130

Actively Recruiting

3

KotiHammas

Vantaa, Uusimaa, Finland, 01600

Actively Recruiting

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Research Team

M

Mikko Kylmänen, Master of Health Care

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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