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Periodontal Care and Glycemic Control in Diabetes

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ClinicalTrials.gov Identifier: NCT00012688
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Colgate-Periogard-Dentsply
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Poor Glycemic Control Peridontal Disease Drug: Doxycycline HCI 10mg po for 2 weeks Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Periodontal Care and Glycemic Control in Diabetes
Actual Study Completion Date : September 2003
Arms and Interventions
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Arm Intervention/treatment
Arm 1 Drug: Doxycycline HCI 10mg po for 2 weeks Procedure: Ultrasonic scaling with 0.12% chlorhexidine gluconate


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00012688     History of Changes
Other Study ID Numbers: DII 99-206
First Posted: March 16, 2001    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: February 2007

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