Type 2 Diabetes Clinical Trial
Official title:
A Randomized, Controlled Trial Comparing the Stability of SLA Implants and SLActive Implants Using Resonance Frequency Analysis for Patients With Type 2 Diabetes Mellitus
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.
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
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