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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128374
• Other study ID #: UL1RR024148 (CTSA)
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: January 14, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center Houston, Dental Branch	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c percentage		At baseline and 120 days after treatment	No
Secondary	microbial burden		Baseline and 120 days after therapy	No
Secondary	gene polymorphisms		120 days after enrolment	No