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

RecruitingNAAges 65 Years - anyAllKoite Health Oy
NCT06576063 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 re

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📋 Eligibility rules (as published)
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.
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What it tests

  • Lumoral Treatment
  • Standard oral hygiene methods
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Where

3 sites
SuperSuu
Loviisa, Finland
SuperSuu
Sipoo, Finland
KotiHammas
Vantaa, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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