Diabetes and Periodontal Therapy Trial (DPTT)

• ClinicalTrials.gov Identifier: NCT00997178
• Recruitment Status: Completed
• First Posted: October 19, 2009
• Last Update Posted: January 20, 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)
• Information provided by (Responsible Party): Stony Brook University

Tracking Information

• First Submitted Date: October 16, 2009
• First Posted Date: October 19, 2009
• Last Update Posted Date: January 20, 2014
• Study Start Date: October 2009
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 16, 2009): Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: 6 months after randomization ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 16, 2009)

• Change in glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months after randomization ]
• Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2) [ Time Frame: 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 ]
• Need for Periodontal Rescue Therapy [ Time Frame: When required ]
• Change in diabetes medications [ Time Frame: 3 and 6 months after randomization ]
• Need for Diabetes Rescue Therapy [ Time Frame: When required ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Diabetes and Periodontal Therapy Trial
• 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

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:

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.

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
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Chronic Periodontitis
• Type 2 Diabetes

Intervention

• 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

Study Arms

• 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
  Intervention: Procedure: Non-surgical periodontal therapy
• Delayed non-surgical periodontal therapy
  No periodontal treatment for 6 months
  Intervention: Other: Delayed non-surgical periodontal therapy

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 17, 2014): 514
• Original Estimated Enrollment (submitted: October 16, 2009): 600
• Actual Study Completion Date: December 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00997178
• Other Study ID Numbers: NIDCR:07-003; U01DE018902-01 ( U.S. NIH Grant/Contract ); U01DE018886-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Stony Brook University
• Original Responsible Party: Judy Matuk M.S. Assistant Vice President for Research Compliance, Stony Brook University
• Current Study Sponsor: Stony Brook University
• Original Study Sponsor: Same as current

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)

Investigators

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

• PRS Account: Stony Brook University
• Verification Date: January 2014