Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853679
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2023-04-21
Brief Title:
Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents
Sponsor:
Koite Health Oy
Organization:
Koite Health Oy
Study Overview
Official Title:
Effect of Regular Antibacterial Photodynamic Therapy on Oral Hygiene in Elderly Residents of a 24-hour Care Facility
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Helsinkis 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
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 Helsinkis 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None