Clinical trial NCT01128374: The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
Official title: The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Periodontal Disease
Keywords: Periodontal disease
Nonsurgical therapy
Type 2 Diabetes Mellitus
Bacterial burden
Gene polymorphisms
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2010-05-21
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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)

Primary outcomes:
measure: HbA1c percentage
timeFrame: At baseline and 120 days after treatment
Secondary outcomes:
measure: microbial burden
timeFrame: Baseline and 120 days after therapy
measure: gene polymorphisms
timeFrame: 120 days after enrolment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center Houston, Dental Branch
state: Texas
Study officials:
affiliation: University of Texas Health Science Center Dental Branch
name: Isabel C Gay, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Science Center at Houston Dental Branch
name: James Katancik, DDS, PhD
role: STUDY_CHAIR
affiliation: University of Texas Health science Center Houston Dental Branch
name: Gena Tribble, PhD
role: STUDY_DIRECTOR
References:
citation: Gay IC, Tran DT, Cavender AC, Weltman R, Chang J, Luckenbach E, Tribble GD. The effect of periodontal therapy on glycaemic control in a Hispanic population with type 2 diabetes: a randomized controlled trial. J Clin Periodontol. 2014 Jul;41(7):673-80. doi: 10.1111/jcpe.12268. Epub 2014 Jun 1.