Clinical trial NCT05853679: Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents
Official title: Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Pus Collection
Oral Disease
Dryness Oral
Tooth Decay
Keywords: Lumoral
Lumorinse
Plaque Control
Anti-bacterial photodynamic therapy
aMMP-8
Care home
Lead sponsor: Koite Health Oy
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: City of Helsinki
First posted: 2023-05-11
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Around 40 people will participate in the study. The study participants will be recruited from service homes in the City of Helsinki. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a home care unit according to a separate instruction manual. At the beginning of the study, all subjects will receive an oral cleaning and will also be provided with electric toothbrushes. In addition, residents and care home personnel will be instructed on daily tooth cleaning.

During the study, all participants will undergo clinical measurements and an assessment of the oral inflammatory load. The samples will be stored for later analysis. In addition, residents or care home personnel answer questions about oral self-care. These measurements and examinations will be carried out at the start of the study and two months after the start of the study. After the end of the study, participants will continue to be treated according to their usual care and individual care plan.

Detailed description: The aim of this study is to investigate the effect of regular antibacterial photodynamic treatment in service accommodation on the oral hygiene of elderly people. The information from this study can be used to promote oral hygiene among residents in 24-hour care.

Lumoral is a CE-marked medical home appliance that has been shown to be effective in reducing plaque development and the amount of harmful bacteria in plaque. The efficacy of the device is based on an antibacterial photodynamic process, whereby a photosensitive substance in Lumorinse attaches itself to the bacterial coating and is activated as an antibacterial agent by light. The antibacterial effect is directly targeted at the plaque, reducing the impact on the normal oral flora. Preliminary studies have shown that the method reduces the inflammatory factors associated with periodontitis.

The study is being carried out in collaboration with the City of Helsinki Oral Health Department, the Metropolia University of Applied Sciences Oral Care Teaching Hospital and the University of Helsinki Department of Oral and Maxillofacial Surgery. The registrar of the study is the University of Helsinki. The study will be conducted in accordance with Good Clinical Practice (GCP) and ISO 14155 ("Clinical trials on medical devices. Good Clinical Practice").

The target population of the study will be residents in 24-hour care with at least 10 of their own teeth, who are judged by the caregiver to be able to participate in the study and who give written informed consent to participate in the study.

Approximately 40 people will participate in the study. They will be recruited from the City of Helsinki's service homes. The subjects will be randomized into two groups. One of the groups will receive daily photodynamic Lumoral treatment for 2 months in a residential unit according to a separate instruction manual. At the beginning of the study, all subjects will receive an oral cleaning and will also be provided with electric toothbrushes. In addition, residents and carers will be instructed on daily tooth cleaning.

During the study, all patients will undergo clinical measurements (VPI, CPITN, dry mouth) and an assessment of the oral inflammatory load using the aMMP-8 bowel inflammation test. The occlusion samples will be stored for later analysis. In addition, residents or caregivers answer questions about oral self-care. These measurements and examinations will be carried out at the start of the study and two months after the start of the study. After the end of the study, subjects will continue to be treated according to their usual care and individual care plan.

Eligibility criteria: Inclusion Criteria:

* A 24-hour care resident;
* Understand and able to give consent to the study;
* At least 10 functional teeth in the mouth (including implants);
* Able to brush teeth and follow the instruction for use Lumoral treatment, based on the assessment by the nursing staff.

Exclusion Criteria:

* Incapable of participating in the study based on the assessment of the nursing staff
* Toothless or less than 10 functional teeth in the mouth (including implants)

Primary outcomes:
measure: Change in oral hygiene / patient experience
timeFrame: 2 months
measure: Visible Plaque Index
timeFrame: 2 months
measure: aMMP-8 chaiside test
timeFrame: 2 months
Secondary outcomes:
measure: Dryness in mouth
timeFrame: 2 months
measure: Dryness in mouth (patient experience)
timeFrame: 2 months
measure: Usability of Lumoral Treatment device (patient outcome)
timeFrame: 2 months
measure: Usability of Lumoral Treatment device (care home personnel outcome)
timeFrame: 2 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: City of Helsinki, Health and Social Services, Senior Services
state: Uusimaa
Study officials:
affiliation: University of Helsinki
name: Timo Sorsa, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Helsinki
name: Riitta Saarela
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Tommi Pätilä
role: STUDY_DIRECTOR
References:
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