Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility

Conditions
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Dental Plaque, Pus Collection, Oral Disease, Dryness Oral, Tooth Decay

Intervention / Treatment
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* Device: Lumoral Treatment
* Other: Standard oral hygiene instructions according to the Finnish Dental Association


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumoral Treatment (Study group)<br>A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. The study group shall receive the Lumoral treatment -device, Lumorinse -tablets and instructions for their use. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. | Device: Lumoral Treatment<br>* The device will be used 5 to 7 times per week according to the manufacturer's instructions.<br>|
| Other: Control group<br>A complete clinical intraoral examination shall be performed for all subjects. Same demographic and clinical data will be obtained from subjects in both arms. All subjects shall receive new electric toothbrushes, standard oral hygiene instructions for the use of an electric toothbrush, interdental brush, and dental floss. | Device: Lumoral Treatment<br>* The device will be used 5 to 7 times per week according to the manufacturer's instructions.<br>Other: Standard oral hygiene instructions according to the Finnish Dental Association<br>* Participants will be instructed to clean their teeth twice per day by an electric toothbrush, an interdental brush, and flossing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Dryness in mouth (patient experience) | The data will be obtained by a oral health questionnaire (patient outcome). | 2 months | 
| Usability of Lumoral Treatment device (patient outcome) | The study participants will answer a questionnaire related to the usability of Lumoral Treatment device. | 2 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumoral, Lumorinse, Plaque Control, Anti-bacterial photodynamic therapy, aMMP-8, Care home