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

NCT01128374 | Completed DMC

• 2 other identifiers: UL1RR024148 (CTSA)UL1RR024148
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Periodontal Disease

Keywords

Periodontal disease; Nonsurgical therapy; Type 2 Diabetes Mellitus; Bacterial burden; Gene polymorphisms

Outcome Measures

Primary Outcomes (1)

• HbA1c percentage

  At baseline and 120 days after treatment

Secondary Outcomes (2)

• microbial burden

  Baseline and 120 days after therapy

• gene polymorphisms

  120 days after enrolment

Study Arms (1)

intervention

EXPERIMENTAL

Therapy

Procedure: Periodontal Scaling and root planing

Interventions

Periodontal Scaling and root planing PROCEDURE

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

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hispanic origin as confirmed by patient records

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• University of Alabama at Birmingham: collaborator

Study Sites (1)

The University of Texas Health Science Center Houston, Dental Branch

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 24797222 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases

Interventions

Root Planing

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Isabel C Gay, DDS, MS

  University of Texas Health Science Center Dental Branch

  PRINCIPAL INVESTIGATOR

• James Katancik, DDS, PhD

  University of Texas Health Science Center at Houston Dental Branch

  STUDY CHAIR

• Gena Tribble, PhD

  University of Texas Health science Center Houston Dental Branch

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Periodontics, UT Houston Dental Branch

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)