search
Back to results

Diabetes and Periodontal Therapy Trial (DPTT)

Primary Purpose

Chronic Periodontitis, Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Non-surgical periodontal therapy
Delayed non-surgical periodontal therapy
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Diabetes, Diabetes Mellitus, Periodontal Disease, Periodontitis, Glycosylated Hemoglobin, HbA1c

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Site: University of Alabama at Birmingham
  • Clinical Site: University of Minnesota
  • Core Laboratory: University of Minnesota
  • Coordinating Center: Stony Brook University-
  • Administrative Center/Study Chair's Office: Stony Brook University
  • Clinical Site: Stony Brook University
  • University of Texas, Health Sciences Center at Houston
  • Clinical Site: University of Texas Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Non-surgical periodontal therapy

Delayed non-surgical periodontal therapy

Arm Description

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

No periodontal treatment for 6 months

Outcomes

Primary Outcome Measures

Change in Glycosylated Hemoglobin (HbA1c)

Secondary Outcome Measures

Change in glycosylated hemoglobin (HbA1c)
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)
Need for Periodontal Rescue Therapy
Change in diabetes medications
Need for Diabetes Rescue Therapy

Full Information

First Posted
October 16, 2009
Last Updated
January 17, 2014
Sponsor
Stony Brook University
Collaborators
University of Alabama at Birmingham, University of Minnesota, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, National Institute of Dental and Craniofacial Research (NIDCR)
search

1. Study Identification

Unique Protocol Identification Number
NCT00997178
Brief Title
Diabetes and Periodontal Therapy Trial
Acronym
DPTT
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stony Brook University
Collaborators
University of Alabama at Birmingham, University of Minnesota, The University of Texas Health Science Center, Houston, The University of Texas Health Science Center at San Antonio, National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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). 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Type 2 Diabetes
Keywords
Diabetes, Diabetes Mellitus, Periodontal Disease, Periodontitis, Glycosylated Hemoglobin, HbA1c

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
514 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-surgical periodontal therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Delayed non-surgical periodontal therapy
Arm Type
Other
Arm Description
No periodontal treatment for 6 months
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
Non-surgical periodontal therapy (scaling and root planing)and supportive periodontal therapy with chlorhexidine rinse
Intervention Type
Other
Intervention Name(s)
Delayed non-surgical periodontal therapy
Intervention Description
Delayed non-surgical periodontal therapy (scaling and root planing) after the 6 month visit
Primary Outcome Measure Information:
Title
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Change in glycosylated hemoglobin (HbA1c)
Time Frame
3 months after randomization
Title
Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)
Time Frame
3 and 6 months after randomization
Title
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
Title
Need for Periodontal Rescue Therapy
Time Frame
When required
Title
Change in diabetes medications
Time Frame
3 and 6 months after randomization
Title
Need for Diabetes Rescue Therapy
Time Frame
When required

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Engebretson, DMD, MS, MS
Organizational Affiliation
Stony Brook University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leslie Hyman, PhD
Organizational Affiliation
Stony Brook University
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Site: University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Clinical Site: University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Core Laboratory: University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Coordinating Center: Stony Brook University-
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8036
Country
United States
Facility Name
Administrative Center/Study Chair's Office: Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Clinical Site: Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
University of Texas, Health Sciences Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Site: University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24346989
Citation
Engebretson SP, Hyman LG, Michalowicz BS, Schoenfeld ER, Gelato MC, Hou W, Seaquist ER, Reddy MS, Lewis CE, Oates TW, Tripathy D, Katancik JA, Orlander PR, Paquette DW, Hanson NQ, Tsai MY. The effect of nonsurgical periodontal therapy on hemoglobin A1c levels in persons with type 2 diabetes and chronic periodontitis: a randomized clinical trial. JAMA. 2013 Dec 18;310(23):2523-32. doi: 10.1001/jama.2013.282431.
Results Reference
result
PubMed Identifier
27108476
Citation
Geisinger ML, Michalowicz BS, Hou W, Schoenfeld E, Gelato M, Engebretson SP, Reddy MS, Hyman L. Systemic Inflammatory Biomarkers and Their Association With Periodontal and Diabetes-Related Factors in the Diabetes and Periodontal Therapy Trial, A Randomized Controlled Trial. J Periodontol. 2016 Aug;87(8):900-13. doi: 10.1902/jop.2016.150727. Epub 2016 Apr 25.
Results Reference
derived
PubMed Identifier
24080100
Citation
DPTT study group; Engebretson S, Gelato M, Hyman L, Michalowicz BS, Schoenfeld E. Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis. Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.
Results Reference
derived

Learn more about this trial

Diabetes and Periodontal Therapy Trial

We'll reach out to this number within 24 hrs