Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
ID06576063

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

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

100

Participants Needed

3

Research Sites

26 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

The aging population worldwide is growing rapidly, with more elderly people retaining their natural teeth than before. Maintaining oral health is crucial for older adults, as poor dental condition can lead to complications like infections and reduced quality of life. This research evaluates the use of antibacterial photodynamic therapy (aPDT) combined with antibacterial blue light (aBL) using the Lumoral device, alongside regular dental care, to help improve oral hygiene in elderly people living at home or in care homes. Participants will be divided into two groups: one group will use the Lumoral Treatment device at home combined with standard oral hygiene methods, while the other group will follow only standard oral hygiene practices. The Lumoral device uses a photosensitive mouthwash activated by light to target harmful bacteria in dental plaque. The study will last 9 months, during which participants will receive regular dental appointments and instructions on oral care. Throughout the study, participants will be monitored with dental examinations measuring bleeding on probing, plaque levels, periodontal pocket depth, oral bacterial flora, mouth dryness, and quality of life related to oral health. Safety will be tracked by recording any adverse events. The study aims to assess how the Lumoral Treatment affects oral hygiene, inflammation, and mouth dryness in elderly individuals over this period.

CONDITIONS

Brief 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...

  • Age 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
  • At least 10 teeth in the mouth, including implants
  • Ability to understand and follow the study protocol, including tooth brushing and use of the Lumoral Treatment device 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
  • Any physical limitation restricting use of the Lumoral device
  • Active smoking or use of other tobacco products
  • Antibiotic use within 4 weeks prior to 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 9 months

Participants use standard oral hygiene methods at home. The study group also uses the Lumoral photodynamic antibacterial dual-light device with a marker substance as an adjunctive treatment to improve oral hygiene, reduce inflammation, and alleviate dry mouth.

Regular visits for oral health assessments during the 9-month treatment period

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

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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Frequently Asked Questions

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Published Research Related To This Trial

Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study.

Hanna Lähteenmäki, Tommi Pätilä, Ismo T Räisänen...

https://pubmed.ncbi.nlm.nih.gov/35723308