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Search / Trial NCT06576063

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

Launched by KOITE HEALTH OY · Aug 26, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lumoral Preventive Oral Care Antibacterial Photodynamic Therapy (A Bpt) A Mmp 8 Plaque Control Oral Hygiene

ClinConnect Summary

This clinical trial is studying a new way to help elderly people maintain better oral health by using a special device called Lumoral, which combines two techniques: antibacterial photodynamic therapy and antibacterial blue light. These methods aim to reduce dental plaque and harmful bacteria in the mouth, which can lead to issues like bleeding gums and other oral complications. The trial will explore how regular visits to the dentist, combined with this new home treatment, can improve oral hygiene for older adults.

To participate in the study, individuals must be at least 65 years old, living at home or in a care facility, and able to keep regular dental appointments. They should also have at least 10 teeth, including any implants, and be able to understand and follow instructions for using the Lumoral device. Participants can expect to learn more about their oral health and receive support in using the device effectively. It's important to note that certain health conditions and recent use of medications may prevent someone from joining the trial, but those who qualify could play a key role in improving oral health care for the aging population.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • 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.

About Koite Health Oy

Koite Health Oy is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Based in Finland, the company specializes in designing and managing clinical trials that focus on cutting-edge therapies and medical technologies. With a commitment to improving patient outcomes, Koite Health Oy leverages a team of experienced professionals and robust methodologies to ensure the highest standards of quality and compliance throughout the research process. By fostering collaborations with healthcare providers and stakeholders, Koite Health Oy aims to bring transformative solutions to the market, enhancing the efficacy and accessibility of treatments for various medical conditions.

Locations

Loviisa, Uusimaa, Finland

Sipoo, Uusimaa, Finland

Vantaa, Uusimaa, Finland

Patients applied

0 patients applied

Trial Officials

Timo Sorsa, Professor

Principal Investigator

University of Helsinki

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported