The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Isabel Gay, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01128374
First received: May 20, 2010
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the population in the United States affected. Moreover, up to one-third of these individuals may not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American population, prevalence rates may be up to 50%. Contributing factors such as poor education, low household income, language barriers and restricted access to medical services may increase this prevalence. The association between periodontal disease and diabetes has been well documented; however, interventional studies have resulted in conflicting conclusions on improvements in glycemic control following periodontal therapy.

Diabetes and periodontal disease share common pathways in pathogenesis, such as their polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the investigators, propose this randomized controlled trial designed to elucidate how treatment of periodontal disease can be used for preventive and therapeutic purposes in a diabetic population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is that the Mexican-American T2DM population in Texas is at risk for an increased presence and severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms; furthermore we suggest that providing non-surgical periodontal therapy to this group will decrease the bacterial load associated with disease and as a consequence, will improve glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors associated with the presence of periodontal disease and to understand how the treatment of periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2 diabetic population.


Condition Intervention
Type 2 Diabetes Mellitus
Periodontal Disease
Procedure: Periodontal Scaling and root planing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • HbA1c percentage [ Time Frame: At baseline and 120 days after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • microbial burden [ Time Frame: Baseline and 120 days after therapy ] [ Designated as safety issue: No ]
  • gene polymorphisms [ Time Frame: 120 days after enrolment ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention
Therapy
Procedure: Periodontal Scaling and root planing
Participants will be instructed to brush their teeth using the modified Bass toothbrushing technique; the use of interproximal hygiene aids such as proximal brush or dental floss will be included. A full mouth scaling and root planning will be performed in 2 appointments (2 hours each) with the use of local anesthesia (typically 2% lidocaine with 1:100,000 epinephrine). In the control group, this treatment will be performed after all the data and samples have been collected and will encompass the last 2visits. Periodontal scaling and root planning treatment has been defined by The American Academy of Periodontology (AAP) as the standard of care for patients with periodontal disease. An ultrasonic instrument, scalers and curettes will be utilized to remove calculus and obtain a smooth root surface. The experimental subjects will be appointed 1 week later to complete the scaling and root planning procedure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Diagnosed type 2 diabetes mellitus
  • Existence of moderate to severe periodontitis as defined by the American Academy of Periodontology
  • In good general health - able to undergo the proposed therapy without compromise to existing health
  • Demonstrated ability to read and understand written Spanish or English without the aid of ad-hoc interpretation by a third party
  • Demonstrated ability to understand the proposed therapy and possible outcome
  • Demonstrated willingness to comply with all protocol requirements as outlined in the informed consent document
  • Willingness/ability to sign an informed consent document for their own inclusion in the study
  • Hispanic origin as confirmed by patient records

Exclusion Criteria:

  • Pregnancy at the time of enrollment (Pregnancy test is required for female study participants of child-bearing potential.)
  • Use of antibiotics within last 3 months
  • Immunocompromised health status
  • Other medical conditions that represent a threat to life
  • Osteoporosis
  • Biphosphonates, corticosteroids or behavior alteration medications
  • Historical abuse of alcohol or drugs
  • Use of cigarettes/tobacco products within the past 12 months
  • Mental diseases
  • Any other oral pathology that compromise the patient's medical status
  • Diagnosed type 1 diabetes mellitus (Information will be obtained from the medical records)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01128374

Locations
United States, Texas
The University of Texas Health Science Center Houston, Dental Branch
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
Investigators
Principal Investigator: Isabel C Gay, DDS, MS University of Texas Health Science Center Dental Branch
Study Chair: James Katancik, DDS, PhD University of Texas Health Science Center at Houston Dental Branch
Study Director: Gena Tribble, PhD University of Texas Health science Center Houston Dental Branch
  More Information

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Isabel Gay, Assistant Professor - Periodontics, UT Houston Dental Branch, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01128374     History of Changes
Other Study ID Numbers: UL1RR024148 (CTSA)
Study First Received: May 20, 2010
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Periodontal disease
Nonsurgical therapy
Type 2 Diabetes Mellitus
Bacterial burden
Gene polymorphisms

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

ClinicalTrials.gov processed this record on September 18, 2014