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
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
Doxycycline hyclate
Doxycycline
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 15, 2014