Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05871229
Status:
COMPLETED
Last Update Posted:
2023-08-09
First Post:
2023-05-03
Brief Title:
Prevention of Dental Implant Diseases
Sponsor:
Hanna Lähteenmäki
Organization:
Koite Health Oy
Study Overview
Official Title:
Prevention of Dental Implant Diseases Early Diagnosis and Monitoring in Clinical Work and Enhanced Oral Health Maintenance at Home
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:
The aim of this study is to determine the effect of regular antibacterial photodynamic Lumoral treatment on gingival health and plaque volume and anti-inflammatory effect of daily double light therapy on implant teeth The study will use a medical device containing a light-activated Lumorinse mouthwash and a Lumoral light activator
Detailed Description:
The hypothesis is that antibacterial photodynamic therapy improves tissue health by reducing inflammation without any side effect
Study participants will be invited from a dental clinic in Tampere Finland from the patients of an oral hygienists office Participants will be randomized to the treatment and control groups using the closed envelope method Participants in the treatment group will receive Lumoral treatment according to the manufacturers protocol once daily for 10 min for 15 days and then twice daily for 15 days
Study participants will be invited from a dental clinic in Tampere Finland from the patients of an oral hygienists office Participants will be randomized to the treatment and control groups using the closed envelope method Participants in the treatment group will receive Lumoral treatment according to the manufacturers protocol once daily for 10 min for 15 days and then twice daily for 15 days
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