Diabetes and Periodontal Therapy Trial (DPTT)

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
The University of Texas Health Science Center, Houston
The University of Texas Health Science Center at San Antonio
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00997178
First received: October 16, 2009
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention Phase
Chronic Periodontitis
Type 2 Diabetes
Procedure: Non-surgical periodontal therapy
Other: Delayed non-surgical periodontal therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months after randomization ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2) [ Time Frame: 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Need for Periodontal Rescue Therapy [ Time Frame: When required ] [ Designated as safety issue: Yes ]
  • Change in diabetes medications [ Time Frame: 3 and 6 months after randomization ] [ Designated as safety issue: No ]
  • Need for Diabetes Rescue Therapy [ Time Frame: When required ] [ Designated as safety issue: Yes ]

Enrollment: 514
Study Start Date: October 2009
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00997178

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT00997178     History of Changes
Other Study ID Numbers: NIDCR:07-003, UO1 DE018902-01, UO1 DE018886-01
Study First Received: October 16, 2009
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Diabetes
Diabetes Mellitus
Periodontal Disease
Periodontitis
Glycosylated Hemoglobin
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontitis
Chronic Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014