The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus, Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Periodontal Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Periodontal disease, Nonsurgical therapy, Type 2 Diabetes Mellitus, Bacterial burden, Gene polymorphisms
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)
Sites / Locations
- The University of Texas Health Science Center Houston, Dental Branch
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
Therapy
Outcomes
Primary Outcome Measures
HbA1c percentage
Secondary Outcome Measures
microbial burden
gene polymorphisms
Full Information
NCT ID
NCT01128374
First Posted
May 20, 2010
Last Updated
January 14, 2013
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01128374
Brief Title
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
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Periodontal Disease
Keywords
Periodontal disease, Nonsurgical therapy, Type 2 Diabetes Mellitus, Bacterial burden, Gene polymorphisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention
Arm Type
Experimental
Arm Description
Therapy
Intervention Type
Procedure
Intervention Name(s)
Periodontal Scaling and root planing
Intervention Description
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
Primary Outcome Measure Information:
Title
HbA1c percentage
Time Frame
At baseline and 120 days after treatment
Secondary Outcome Measure Information:
Title
microbial burden
Time Frame
Baseline and 120 days after therapy
Title
gene polymorphisms
Time Frame
120 days after enrolment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel C Gay, DDS, MS
Organizational Affiliation
University of Texas Health Science Center Dental Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James Katancik, DDS, PhD
Organizational Affiliation
University of Texas Health Science Center at Houston Dental Branch
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gena Tribble, PhD
Organizational Affiliation
University of Texas Health science Center Houston Dental Branch
Official's Role
Study Director
Facility Information:
Facility Name
The University of Texas Health Science Center Houston, Dental Branch
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24797222
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.
Results Reference
derived
Learn more about this trial
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
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