Using antibacterial light therapy to improve oral hygiene in elderly people
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
NA · Koite Health Oy · NCT06576063
This study tests if using a special blue light device along with regular brushing can help older adults keep their mouths healthier and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Koite Health Oy (industry) |
| Locations | 3 sites (Loviisa, Uusimaa and 2 other locations) |
| Trial ID | NCT06576063 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of antibacterial photodynamic therapy (aPDT) combined with standard oral hygiene methods to enhance oral health in elderly individuals. Participants will use the Lumoral device, which employs antibacterial blue light to reduce dental plaque and harmful bacteria. The study aims to assess the impact of this treatment alongside regular dental appointments on maintaining oral hygiene and improving the quality of life for the aging population. The research is motivated by the increasing need for effective oral care solutions as the elderly population grows.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older who can attend regular dental appointments and have at least 10 teeth.
Not a fit: Patients with uncontrolled diabetes, severe dementia, or physical limitations that restrict the use of the Lumoral device may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve oral hygiene and overall health outcomes for elderly patients.
How similar studies have performed: Previous studies have shown promise in using photodynamic therapy for oral health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Loviisa, Uusimaa and 2 other locations
- SuperSuu — Loviisa, Uusimaa, Finland (RECRUITING)
- SuperSuu — Sipoo, Uusimaa, Finland (RECRUITING)
- KotiHammas — Vantaa, Uusimaa, Finland (RECRUITING)
Study contacts
- Principal investigator: Timo Sorsa, Professor — University of Helsinki
- Study coordinator: Mikko Kylmänen, Master of Health Care
- Email: mikko.kylmanen@koitehealth.com
- Phone: +358407245934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dental Plaque, Bleeding of Subgingival Space, Oral Complication, Lumoral, Preventive oral care, Antibacterial photodynamic therapy, aMMP-8, Plaque control