Antibacterial Photodynamic Therapy as an Adjunctive Treatment on Oral Hygiene in Elderly Persons
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorKoite Health Oy
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Lumoral Treatment
- Standard oral hygiene methods
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Koite Health Oy
Lead sponsor
University of Helsinki
Collaborator
Source ClinicalTrials.gov