Periodontal Care and Glycemic Control in Diabetes

Diabetes Mellitus Clinical Trial

Official title:

Periodontal Care and Glycemic Control in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00012688
• Other study ID #: DII 99-206
• Status: Completed
• Phase: N/A
• First received: March 14, 2001
• Last updated: April 6, 2015
• Est. completion date: September 2003

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.

Description:

Background:

Diabetes is a prevalent and costly disease among users of VA care. Goals of diabetes care include the prevention and/or delay of complications via adequate glycemic control. Improvements in periodontal status may also improve diabetes control.

Objectives:

This project will determine the efficacy of a program of periodontal screening and therapy in improving the level of glycemic control in poorly controlled diabetics.

Methods:

Status:

Subject accrual is complete. Data collection is ongoing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients must have diabetes mellitus, and HbAlc >9, >8 teeth, and CPITN scores of 3 or 4 in, at least 2 sextants of the mouth, indicating moderate to high peridontal treatment need.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Peridontal Disease
• Poor Glycemic Control

Intervention

Drug:
• Doxycycline HCI 10mg po for 2 weeks

Procedure:
• Ultrasonic scaling with 0.12% chlorhexidine gluconate

Locations

Country	Name	City	State
United States	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA	Bedford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Colgate-Periogard-Dentsply

Country where clinical trial is conducted

United States, 

References & Publications (5)

Cunha-Cruz J, Hujoel PP, Kressin NR. Oral health-related quality of life of periodontal patients. J Periodontal Res. 2007 Apr;42(2):169-76. — View Citation

Janket SJ, Jones J, Rich S, Miller D, Wehler CJ, Van Dyke TE, Garcia R, Meurman JH. The effects of xerogenic medications on oral mucosa among the Veterans Dental Study participants. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Feb;103(2):223-30. — View Citation

Jones JA, Miller DR, Wehler CJ, Rich S, Krall E, Christiansen CL, Rothendler JA, Garcia RI. Study design, recruitment, and baseline characteristics: the Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):40-5. Epub 20 — View Citation

Jones JA, Miller DR, Wehler CJ, Rich SE, Krall-Kaye EA, McCoy LC, Christiansen CL, Rothendler JA, Garcia RI. Does periodontal care improve glycemic control? The Department of Veterans Affairs Dental Diabetes Study. J Clin Periodontol. 2007 Jan;34(1):46-52 — View Citation

McCoy LC, Wehler CJ, Rich SE, Garcia RI, Miller DR, Jones JA. Adverse events associated with chlorhexidine use: results from the Department of Veterans Affairs Dental Diabetes Study. J Am Dent Assoc. 2008 Feb;139(2):178-83. — View Citation