Diabetes and Periodontal Therapy Trial

NCT00997178 | Completed Phase 3 DMC

• 3 other identifiers: NIDCR:07-003U01DE018902-01U01DE018886-01
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 8

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. 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. 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

Keywords

Diabetes; Diabetes Mellitus; Periodontal Disease; Periodontitis; Glycosylated Hemoglobin; HbA1c

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Hemoglobin (HbA1c)

  6 months after randomization

Secondary Outcomes (6)

• Change in glycosylated hemoglobin (HbA1c)

  3 months after randomization

• Change in Fasting Plasma Glucose and Homeostasis Model Assessment 2 (HOMA2)

  3 and 6 months after randomization

• Change in clinical measures of chronic periodontitis (gingival index, bleeding on probing, probing depth, clinical attachment level)

  3 and 6 months after randomization

• Need for Periodontal Rescue Therapy

  When required

• Change in diabetes medications

  3 and 6 months after randomization

Study Arms (2)

Non-surgical periodontal therapy

EXPERIMENTAL

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

Delayed non-surgical periodontal therapy

OTHER

No periodontal treatment for 6 months

Other: Delayed non-surgical periodontal therapy

Interventions

Non-surgical periodontal therapy PROCEDURE

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

Non-surgical periodontal therapy

Delayed non-surgical periodontal therapy OTHER

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

Delayed non-surgical periodontal therapy

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

Clinical Site: University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Clinical Site: University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Core Laboratory: University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Coordinating Center: Stony Brook University-

Stony Brook, New York, 11794-8036, United States

Location

Administrative Center/Study Chair's Office: Stony Brook University

Stony Brook, New York, 11794, United States

Location

Clinical Site: Stony Brook University

Stony Brook, New York, 11794, United States

Location

University of Texas, Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Clinical Site: University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Related Publications (3)

• 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.

  PMID: 24346989 RESULT

• 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.

  PMID: 27108476 DERIVED

• 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.

  PMID: 24080100 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Diabetes Mellitus, Type 2; Diabetes Mellitus; Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Steven Engebretson, DMD, MS, MS

  Stony Brook University

  STUDY CHAIR

• Leslie Hyman, PhD

  Stony Brook University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

US (8)