Periodontal Care and Glycemic Control in Diabetes - Full Text View

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:

Drug Information available for: Chlorhexidine Doxycycline Chlorhexidine gluconate

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:


Estimated Enrollment:	300
Study Completion Date:	September 2003

Arms	Assigned Interventions
Arm 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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730

Sponsors and Collaborators

VA Office of Research and Development

Colgate-Periogard-Dentsply

Investigators


Principal Investigator:	Judith A. Jones, DDS DSc MPH	Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

More Information

Publications:

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.

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.


Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00012688 History of Changes
Other Study ID Numbers:	DII 99-206
Study First Received:	March 14, 2001
Last Updated:	April 6, 2015
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Chlorhexidine Chlorhexidine gluconate Doxycycline Anti-Infective Agents, Local	Anti-Infective Agents Disinfectants Dermatologic Agents Anti-Bacterial Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents

ClinicalTrials.gov processed this record on September 23, 2016