Diabetes and Periodontal Therapy Trial (DPTT)

January 17, 2014 updated by: Stony Brook University

A Multicenter Randomized Single-Masked Clinical Trial Testing the Effect of Non-surgical Periodontal Therapy on Glycosylated Hemoglobin (HbA1c) Levels in Subjects With Type 2 Diabetes and Chronic Periodontitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, randomized, controlled, single-masked, Phase III trial to determine if non-surgical periodontal therapy (scaling and root planing) is efficacious in reducing elevated glycosylated hemoglobin (HbA1c) at 6 months post-randomization in subjects with type 2 diabetes and untreated, moderate to advanced chronic periodontitis. Six hundred adults with a diagnosis of type 2 diabetes and chronic periodontitis will be randomized at three Clinical Sites; University of Alabama at Birmingham; the University of Minnesota, Minneapolis; and the University of Texas Health Science Center, San Antonio. The Core Laboratory will be located at the University of Minnesota and the Study Chair's Office and Coordinating Center will be located at Stony Brook University, Stony Brook, New York.

Eligible participants will be randomly assigned to receive either initial non-surgical periodontal therapy with chlorhexidine rinse (treatment subjects) or delayed non-surgical periodontal therapy (control subjects). Control subjects will be offered delayed periodontal therapy (scaling and root planing) following the 6 month visit. Participants meeting all other eligibility criteria and needing essential dental care, i.e., for broken, grossly carious or abscessed teeth, may enroll only following completion of necessary dental treatment. Participants in both study arms will receive oral hygiene instruction and healthy lifestyle information (e.g. diet, exercise) at baseline and at the 3 and 6 month visits.

Periodontal data will be recorded by trained and calibrated examiners at baseline and 3 and 6 months following randomization. Fasting blood will collected at baseline and at 3 and 6 months to measure intermediate links in the putative causal chain between periodontitis and glycemic control. The periodontal health of all subjects will be monitored, and any subject who experiences progressive periodontitis during the study will be provided with non-surgical rescue therapy.

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Clinical Site: University of Alabama at Birmingham
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Clinical Site: University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Core Laboratory: University of Minnesota
    • New York
      • Stony Brook, New York, United States, 11794-8036
        • Coordinating Center: Stony Brook University-
      • Stony Brook, New York, United States, 11794
        • Administrative Center/Study Chair's Office: Stony Brook University
      • Stony Brook, New York, United States, 11794
        • Clinical Site: Stony Brook University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, Health Sciences Center at Houston
      • San Antonio, Texas, United States, 78229
        • Clinical Site: University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 35 years of age
  • Screening HbA1c value ≥ 7% and <9%
  • Physician diagnosed type 2 diabetes of more than three months duration
  • Currently under the care of a physician for diabetes management
  • No change in diabetes-related medications during the three months prior to enrollment. Change is defined as any of the following: change in dose of any 1 hyperglycemic drug by more than two-fold, change in dose of insulin of more than 10%, addition or subtraction of an oral hyperglycemic agent or insulin.
  • Consent to contact treating physician and obtain physician agreement to refrain from changing diabetes- related medications during DPTT participation unless overt symptoms develop (e.g. polydipsia, polyuria), HbA1c is 9.5% or higher
  • Moderate to severe chronic periodontitis, defined as loss of clinical attachment and probing depth of ≥5 mm at two sites in the mouth in 2 or more quadrants
  • No definitive periodontal treatment during the six months prior to enrollment
  • Likely to have at least 16 natural teeth for the entire length of study
  • Informed consent obtained and signed
  • Ability and willingness to cooperate with the study protocol and attend all study visits over the next 9 months
  • Willingness to avoid pregnancy during study participation

Exclusion Criteria:

  • Self-reported serious concurrent disease that at the discretion of the referring physician limits life expectancy to less than 1 year.
  • Emergency room visit or physician visit within the last 30 days because of hyperglycemia or diabetes complications.
  • Chronic or continuous use (daily for more than 7 consecutive days) of nonsteroidal anti-inflammatory drugs within the preceding 2 months, other than low dose aspirin (e.g. 75-325 mg/day).
  • Receiving chronic treatment with systemic corticosteroids, cyclosporine or other systemic immunosuppressive drugs
  • Chronic treatment with systemic antibiotics (antibiotics for > 7 consecutive days within 30 days of baseline visit).
  • Currently receiving dialysis.
  • At increased risk of bleeding complications from dental treatment, based on medical history.
  • Requires Essential Dental Care (e.g., treatment for grossly decayed teeth, broken teeth, dental abscesses, peri-apical infections, other dental infections).
  • Heavy alcohol consumption (on average > 2 drinks/day for women and > 3 drinks/day for men).
  • Currently pregnant or considering becoming pregnant within the 6 month follow-up period
  • Any other criteria that in the opinion of the investigator would preclude study completion or problems with compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-surgical periodontal therapy
Non-surgical periodontal therapy consisted of scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months
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
No periodontal treatment for 6 months
Other: Delayed non-surgical periodontal therapy
Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: 6 months after randomization
6 months after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in glycosylated hemoglobin (HbA1c)
Time Frame: 3 months after randomization
3 months after randomization
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
Time Frame: 3 and 6 months after randomization
3 and 6 months after randomization
Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)
Time Frame: 3 and 6 months after randomization
3 and 6 months after randomization
Need for Periodontal Rescue Therapy
Time Frame: When required
When required
Change in diabetes medications
Time Frame: 3 and 6 months after randomization
3 and 6 months after randomization
Need for Diabetes Rescue Therapy
Time Frame: When required
When required

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
National Institute of Dental and Craniofacial Research (NIDCR)
University of Minnesota
The University of Texas Health Science Center at San Antonio

Investigators

  • Study Chair: Steven Engebretson, DMD, MS, MS, Stony Brook University
  • Study Director: Leslie Hyman, PhD, Stony Brook University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDCR:07-003
  • U01DE018902-01 (U.S. NIH Grant/Contract)
  • U01DE018886-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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