Diabetes and Periodontal Therapy Trial

Summary

The primary aim of the study is to determine if non-surgical periodontal therapy (scaling and root planing and supportive periodontal therapy) is efficacious compared to delayed therapy in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis.

The secondary aims of the study are to:

1. evaluate whether 6 month (or shorter-term (3 month)) changes in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level) are related to changes in HbA1c and fasting glucose or insulin resistance as measured by the Homeostasis Model Assessment 2 (HOMA2).
2. assess the 3 month and 6 month efficacy of periodontal therapy on all of the above study outcomes. If a treatment response is observed for any of the study outcomes at 3 months, then the trial can evaluate whether this response is sustained at 6 months.

Conditions

• Chronic Periodontitis
• Type 2 Diabetes

Interventions

PROCEDURE

Non-surgical periodontal therapy

Non-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse

OTHER

Delayed non-surgical periodontal therapy

Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• Stony Brook University

  lead OTHER

Principal Investigators

• Steven Engebretson, DMD, MS, MS · Stony Brook University

• Leslie Hyman, PhD · Stony Brook University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2012-10-31

Completion

2012-12-31

Countries

• United States

Study Locations