Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016835
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2001-06-05
Brief Title:
Treating Periodontal Infection Effects on Glycemic
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Treating Periodontal Infection Effects on Glycemic Control in People With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
The purpose of this project is to obtain important preliminary data necessary to support design of a full scale multicenter randomized clinical trial RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes mellitus
Detailed Description:
There is compelling epidemiological and clinical evidence to suggest that periodontal infection adversely affects glycemic control in people with type 2 diabetes mellitus The purpose of this pilot project is to obtain important preliminary data necessary to support design of a full scale multi-center randomized clinical trial RCT to evaluate the effect of treating periodontal infection on glycemic control in individuals with type 2 diabetes mellitus This current project involves treating periodontal infection to obtain estimates of changes and the variability of those changes over time in the established primary endpoint hemoglobin A1c HbA1c This project will also explore use of several potential secondary endpoints including levels of periodontitis and glucose metabolism-related inflammatory mediators TNF-alpha IL-1-beta IL-6 serum cholesterol triglyceride and lipids Subjects are randomly assigned to 1 of three possible groups for comprehensive periodontal examination specimen collection mechanical periodontal therapy and oral systemic antibiotics or placebo and regular follow-up evaluations and site-specific mechanical periodontal therapy at 3-month intervals for approximately 15 months Two groups receive ultrasonic scaling with local anesthesia as needed local antimicrobial treatment with povidone-iodine irrigation and an oral systemic antibiotic either doxycycline or metronidazole at the initial treatment visit The third group controls receives a placebo and supra-gingival oral prophylaxis and ultrasonic removal of supra-gingival calculus with water irrigation at the initial treatment visit At the 9-month follow-up visit controls receive sub-gingival ultrasonic scaling with povidone-iodine irrigation
Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIHNIDCR for funding a multi-center RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes If results from the full scale clinical trial provide evidence that treating periodontal infection contributes to improved glycemic control then diagnosis and treatment of periodontal infection in subjects with type 2 diabetes could be substantiated as an important component in management of diabetes
Results from this pilot project will be used as preliminary data to support design of an immediate follow-up proposal to NIHNIDCR for funding a multi-center RCT to evaluate the effect of treating periodontal infection on glycemic control in type 2 diabetes If results from the full scale clinical trial provide evidence that treating periodontal infection contributes to improved glycemic control then diagnosis and treatment of periodontal infection in subjects with type 2 diabetes could be substantiated as an important component in management of diabetes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01DE013796-03 | NIH | None | httpsreporternihgovquickSearch5R01DE013796-03 |