A Randomized, Controlled Trial Comparing the Stability of SLA Implants and SLActive Implants Using Resonance Frequency Analysis for Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Partially Edentulous Mandible
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Implant Stability Quotient (ISQ)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study compares the patterns of dental implant stabilization between a standard and chemically modified implant surface in patients with type 2 diabetes. It is hypothesized that the chemically modified surface will enhance early healing events (first 4 months following placement)in diabetes patients with compromises in rate of implant integration.
Detailed Description
This is a prospective randomized study design whereby type 2 diabetic patients will receive 2 implants in the mandible or maxilla to assess implant integration. One implant will be a regular SLA implant; the other will have a SLActive surface. The primary objective of this randomized controlled study is to evaluate the stability of Straumann 4.1 mm diameter implants in the posterior mandible or maxilla of type 2 diabetic patients during the first 12 weeks after implantation using resonance frequency analysis. The control implant is a standard Straumann implant with an SLA® surface and the test implant the same implant design with SLActive® surface. Assessments will utilize resonance frequency analysis (RFA), as a measure of implant integration, and clinical outcomes of implant success. This study will enroll type 2 diabetes patients having glycated hemoglobin (HbA1c) levels from 8.0% to 12% at baseline. The primary objective is to test for statistically significant differences in ISQ values between the test and control implants at 2, 3, 4, 6, 7, 8 weeks and 3 months after surgery. If a difference of 2 Osstell RFA ISQ units is detected at any time point it will be considered that the implant having achieved the higher value is better osseointegrated. This split-mouth study design will assess changes in implant stability from baseline as the primary outcome at the implant level. This study will require 20 patients to detect this difference (SD=2.0 ISQ units) with a power of 80% at the P=0.05 level. Secondary objectives include: * Implant survival and implant success at 1-year post loading. * The nature and frequency of adverse events/complications between the 2 groups will be compared. * Prosthesis success
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females must be at least 18 years of age, and having a diagnosis of type 2 diabetes mellitus occurring over 1 year prior to enrollment (self-reported and verified with physician report, test results, and/or treatment record)
- •Type 2 diabetic patients may be on a modified diet, oral medication, insulin, or combination therapies
- •Glycated hemoglobin A1c (HbA1c) levels of at least 8.0% up to and including 12.0% as reported within 4 weeks of implant placement
- •Have at least two missing teeth in the posterior mandible in FDI positions 4, 5, 6, or 7
- •The tooth at the implant site must have been extracted or lost at least 4 months before the date of implantation
- •Adequate bone quantity at the implant site to permit the insertion of a Straumann Standard or Standard Plus 4.1 mm diameter implant at least 8 mm in length without the use of concurrent bone augmentation techniques, i.e. Implant insertion sites must have sufficient bone height such that the implant will not encroach on vital structures and sufficient width that a minimum of 1 mm lingual and buccal bone will remain
- •Patients must have signed the informed consent form. They must be committed to the study. If the treating clinicians doubt that the patient is willing or will be able to attend all study follow-up visits then the patient should not be admitted to the study
Exclusion Criteria
- •Patients with a history of systemic disease other than type 2 diabetes mellitus that may preclude dental implant therapy (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders)
- •Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements)
- •Diabetic retinopathy requiring imminent or planned surgical intervention
- •Diabetic neuropathy of sufficient severity as to require treatment for control of symptoms
- •Serum creatinine \> 1.6 mg/dl
- •AST (SGOT) or ALT (AGPT) \> 2 times upper limit of normal laboratory range
- •Hypertension, with or without medications, having a systolic pressure \> 185mm Hg or diastolic pressure \> 105mm Hg
- •Patient has significant untreated oral infections or inflammatory lesions
- •Medical conditions requiring prolonged use of steroids
- •History of leukocyte dysfunction and deficiencies
Outcomes
Primary Outcomes
Implant Stability Quotient (ISQ)
Time Frame: 4 months
resonance frequency analysis employed to determine implant stability quotient on a 1-100 point scale with 100 representing the greatest stability.
Secondary Outcomes
- Clinical Success of Implants(1 year)