Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Recruiting now · Not applicable
Conditions studied: Dental Plaque, Bleeding of Subgingival Space, Oral Complication
In brief
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.
Key facts
- Study ID
- NCT06576063
- Run by
- Koite Health Oy
- People needed
- 100
- Starts
- 2025-01-02
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-07
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- SuperSuu — Loviisa, Uusimaa, Finland (enrolling)
- SuperSuu — Sipoo, Uusimaa, Finland (enrolling)
- KotiHammas — Vantaa, Uusimaa, Finland (enrolling)
Full record on ClinicalTrials.gov
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