Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816941
Status:
COMPLETED
Last Update Posted:
2023-05-18
First Post:
2023-03-17
Brief Title:
Antimicrobial Photodynamic Therapy in Patients With Periodontal Disease and Type 2 Diabetes Mellitus
Sponsor:
University of Ljubljana
Organization:
University of Ljubljana
Study Overview
Official Title:
The Effect of Antimicrobial Photodynamic Therapy on Periodontal Disease and Glycemic Control in Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Objectives This study aimed to determine the effect of concomitant antimicrobial photodynamic therapy aPTD on periodontal disease and glycaemic control in patients with type 2 diabetes mellitus T2DM
Clinical Relevance aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome
Clinical Relevance aPTD is a noninvasive adjunctive therapy that can positively influence the periodontal treatment outcome
Detailed Description:
Numerous studies confirm that diabetes mellitus increases the risk of gingivitis and periodontitis However periodontal disease also impairs glycaemic control in people with diabetes mellitus via inflammatory mediators
Methods
Twenty-four patients with T2DM were enrolled in the study Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth PPD bleeding on probing BOP clinical attachment loss CAL plaque index PI and sulcus bleeding index SBI Glycated haemoglobin A1c HbA1c was measured To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans Prevotella intermedia Porphyromonas gingivalis Tannerella forsythia and Treponema denticola subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips Patients were randomly divided into the test and control group In the test group complete oral disinfection was performed in combination with aPTD In the control group only complete oral disinfection was performed
Methods
Twenty-four patients with T2DM were enrolled in the study Periodontal tissue status and periodontal disease were assessed by measuring probing pocket depth PPD bleeding on probing BOP clinical attachment loss CAL plaque index PI and sulcus bleeding index SBI Glycated haemoglobin A1c HbA1c was measured To determine the presence of the following periodontal pathogenic bacteria Aggregatibacter actinomycetemcomitans Prevotella intermedia Porphyromonas gingivalis Tannerella forsythia and Treponema denticola subgingival plaque samples were taken from two periodontal pockets with the greatest PPD using paper tips Patients were randomly divided into the test and control group In the test group complete oral disinfection was performed in combination with aPTD In the control group only complete oral disinfection was performed
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?:
False
Is an FDA AA801 Violation?:
None