Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017817
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-08-24
Brief Title:
Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
Sponsor:
Nilminie Rathnayake
Organization:
Koite Health Oy
Study Overview
Official Title:
Regular Home-use of Antibacterial Photodynamic Therapy in the Management of Peri-implantitis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This early-stage study is designed to determine the efficacy of the Lumoral method in periimplantitis Improved supragingival plaque control can help to also sustain subgingival plaque management in the long term In addition the device might have a photobiomodulation effect on periodontal tissues thus impacting osseointegration
Detailed Description:
Clinical signs of inflammation in peri-implantitis include bleeding on probing suppuration increased probing depth and radiographic signs of bone loss Currently the best treatment options for peri-implantitis include non-surgical methods of biofilm removal in the supra-mucosal area around implants and comprehensive guidance on self-performed infection control procedures With more advanced peri-implantitis anti-infective surgical treatment protocol would be needed
Matrix metalloproteinase 8 MMP-8 has been found to be elevated in association with oral infections such as periodontitis and peri-implantitis The level of active MMP-8 aMMP-8 can detect to determine tissue health and to assess inflammation and can easily be measured during a regular dental appointment with a chairside test
The Lumoral Treatment is a CE-marked medical device developed to provide a potent targeted antibacterial action on dental plaque in a home environment The method mechanism of action is antibacterial photodynamic therapy aPDT The method is used by swishing a mouth rinse which has a strong adherence to dental plaque The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction
Matrix metalloproteinase 8 MMP-8 has been found to be elevated in association with oral infections such as periodontitis and peri-implantitis The level of active MMP-8 aMMP-8 can detect to determine tissue health and to assess inflammation and can easily be measured during a regular dental appointment with a chairside test
The Lumoral Treatment is a CE-marked medical device developed to provide a potent targeted antibacterial action on dental plaque in a home environment The method mechanism of action is antibacterial photodynamic therapy aPDT The method is used by swishing a mouth rinse which has a strong adherence to dental plaque The plaque-adhered photoactive mouth rinse can be activated by a simple-to-use light applicator Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction
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