Periodontal Care and Glycemic Control in Diabetes

This study has been completed.
Sponsor:
Collaborator:
Colgate-Periogard-Dentsply
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012688
First received: March 14, 2001
Last updated: February 6, 2014
Last verified: February 2007
  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:


Further study details as provided by Department of Veterans Affairs:

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

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
VA New England Health Care System
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Colgate-Periogard-Dentsply
Investigators
Principal Investigator: Judith A. Jones, DDS MPH DSc VA New England Health Care System
  More Information

Publications:
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: February 6, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on September 16, 2014