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

May 20, 2010
January 14, 2013
June 2010
September 2012   (final data collection date for primary outcome measure)
HbA1c percentage [ Time Frame: At baseline and 120 days after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01128374 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Periodontal Disease
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
Experimental: intervention
Therapy
Intervention: Procedure: Periodontal Scaling and root planing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
134
December 2012
September 2012   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128374
UL1RR024148 (CTSA)
Yes
Isabel Gay, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
University of Alabama at Birmingham
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
The University of Texas Health Science Center, Houston
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP