Periodontal Care and Glycemic Control in Diabetes - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborator:	Colgate-Periogard-Dentsply
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00012688

Purpose

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.

Condition	Intervention
Diabetes Mellitus Poor Glycemic Control Peridontal Disease	Drug: Doxycycline HCI 10mg po for 2 weeks Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	Periodontal Care and Glycemic Control in Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

Drug Information available for: Chlorhexidine Doxycycline Chlorhexidine digluconate Doxycycline hyclate Hibiclens Doxycycline calcium Gluconic acid D-Gluconic acid, monosodium salt Manganese gluconate

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	300
Study Completion Date:	September 2003

Arms	Assigned Interventions
1	Drug: Doxycycline HCI 10mg po for 2 weeks Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012688

Locations

United States, Massachusetts
VA Medical Center (CHQOER)
Bedford, Massachusetts, United States, 01730
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130

Sponsors and Collaborators

Department of Veterans Affairs

Colgate-Periogard-Dentsply

Investigators

Principal Investigator:

Judith A. Jones, DDS MPH DSc

VA New England Health Care System

More Information

Publications:

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. Epub 2006 Aug 4.

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. Epub 2006 Nov 24.

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 2006 Oct 13.

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.

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.

Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00012688 History of Changes
Other Study ID Numbers:	DII 99-206
Study First Received:	March 14, 2001
Last Updated:	January 27, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chlorhexidine gluconate
Chlorhexidine
Doxycycline hyclate
Doxycycline
Anti-Infective Agents, Local

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Disinfectants
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 12, 2012