Ignite Creation Date:
2024-07-17 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486012
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-26
Brief Title:
Regular Use of aPDT in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients
Sponsor:
Wellbeing Services County of Pirkanmaa
Organization:
Wellbeing Services County of Pirkanmaa
Study Overview
Official Title:
Regular Use of Antibacterial Photodynamic Therapy in the Management and Prevention of Periodontitis Symptoms in Diabetic Patients - Special Attention to Diabetic Balance and Metabolism
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
APDT-T2D
Brief Summary:
This is an investigator-initiated clinical study to establish easy referral and access for diabetic patients from primary health care to oral health care facilities for preventive oral care periodontal assessment and treatment and to investigate the impact of regular home use of aPDT medical device on plaque control and gingival health when used as an adjunct treatment to standard oral hygiene and the effect on diabetes control in patients with the risk of periodontal disease compared to a standard home care oral hygiene regimen
Detailed Description:
In earlier studies a bi-directional link between diabetes and periodontitis has been established high glucose levels increase the risk of periodontitis while glycemic control is likely to worsen with untreated periodontitis The treatment of diabetic patients should include easy access from diabetes clinics to oral health care facilities to reduce the potential risks of periodontal disease or deterioration of existing symptoms of periodontal disease As part of a holistic approach to healthcare and its resources more attention needs to be paid to the early detection and prevention of oral diseases in diabetic patients Novel testing and treatment methods can play a key role and a good collaboration between diabetes and oral health care facilities is essential
The aMMP-8 test can be used to assess the risk of periodontal disease If the test is positive latent MMP-8 is activated so the inflammatory cascade is activated and provides real-time information The test can also be used to monitor the success of the treatment outcome and can be used to determine the interval between maintenance treatments In addition patients oral self-care should be improved as most of the work in preventing oral diseases is done at home The home use of photodynamic dual light therapy aPDT can provide additional benefits and also engage patients not only in self-care but also in the whole treatment process Preliminary studies show that aPDT improves the treatment and maintenance outcomes and potentially reduces the risk of periodontal disease in addition to self-care
The combination of easy access to treatment could have wide benefits individually and also at the community level including the possibility of building a cost-effective preventive care pathway for patients with prediabetes type 2 diabetes and periodontitis and identifying the risks of both diseases and treating already detected diseases early and in a timely manner
The aMMP-8 test can be used to assess the risk of periodontal disease If the test is positive latent MMP-8 is activated so the inflammatory cascade is activated and provides real-time information The test can also be used to monitor the success of the treatment outcome and can be used to determine the interval between maintenance treatments In addition patients oral self-care should be improved as most of the work in preventing oral diseases is done at home The home use of photodynamic dual light therapy aPDT can provide additional benefits and also engage patients not only in self-care but also in the whole treatment process Preliminary studies show that aPDT improves the treatment and maintenance outcomes and potentially reduces the risk of periodontal disease in addition to self-care
The combination of easy access to treatment could have wide benefits individually and also at the community level including the possibility of building a cost-effective preventive care pathway for patients with prediabetes type 2 diabetes and periodontitis and identifying the risks of both diseases and treating already detected diseases early and in a timely manner
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