Dental Plaque Clinical Trial
Official title:
Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility
Verified date | August 2023 |
Source | Koite Health Oy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | April 18, 2023 |
Est. primary completion date | April 18, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Finland | City of Helsinki, Health and Social Services, Senior Services | Helsinki | Uusimaa |
Lead Sponsor | Collaborator |
---|---|
Koite Health Oy | City of Helsinki, University of Helsinki |
Finland,
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Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085. — View Citation
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Saarela RKT, Hiltunen K, Kautiainen H, Roitto HM, Mantyla P, Pitkala KH. Oral hygiene and health-related quality of life in institutionalized older people. Eur Geriatr Med. 2022 Feb;13(1):213-220. doi: 10.1007/s41999-021-00547-8. Epub 2021 Jul 27. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in oral hygiene / patient experience | A change in baseline oral self-care and hygiene questionnaire compared to 2-month follow-up.
The questionnaires are completed by the study participants. |
2 months | |
Primary | Visible Plaque Index | Change in Visible Plaque Index:
A full-mouth assessment at 4 sites per tooth will be made at baseline and at the 2 month follow-up visit VPI is reported as the percentage (%) of sites with positive findings Dichotomous scoring to each site of the tooth as plaque" 1 present" and" 0 absent" Calculation formula: number of plaque sites/ 4 times number of teeth |
2 months | |
Primary | aMMP-8 chaiside test | Change in oral inflammatory load measured by the aMMP-8 chairside speed test:
The aMMP-8 marker analysis will be performed using the Periosafe chair-side test (Dentognostics GmbH) according to the manufacturer's instructions. Oral rinse samples will be stored for further analysis. Further analysis includes aMMP-8 and its regulators by biochemical enzyme/molecule assays, immunoassays, and proteomics analysis. |
2 months | |
Secondary | Dryness in mouth | Change in dryness in mouth. The data will be obtained by the thorough oral inspection performed by the investigators, and by a questionnaire (patient outcome).
Clinical assessment of moisture/dryness of oral mucosa (score 0-2): 0 = Saliva secretion looks normal (saliva serous and running) = Mucous membrane of the mouth shiny and tightening/ saliva foamy or mucous/ little clear saliva at the base of the mouth = Mouth completely dry, mirror sticking to cheek or tongue, mucous membranes often reddened/ bumps on tongue surface disappeared/ scab on melting. |
2 months | |
Secondary | Dryness in mouth (patient experience) | The data will be obtained by a oral health questionnaire (patient outcome). | 2 months | |
Secondary | Usability of Lumoral Treatment device (patient outcome) | The study participants will answer a questionnaire related to the usability of Lumoral Treatment device. | 2 months | |
Secondary | Usability of Lumoral Treatment device (care home personnel outcome) | The care home nursing staff will answer a questionnaire related to their view of the usability of Lumoral Treatment device. The questionnaire will also ask about how easy or hard it was to instruct the care home patients to use the device on a near-daily basis and if they would recommend the device for further use or to their customers. | 2 months |
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