NCT01142297

Comparative Study of Implant Surfaces to Enhance Stabilization in Patients With Type 2 Diabetes

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Partially Edentulous Mandible
• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	dental implant and modified dental implant	standard SLA surface and chemically modified surface

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-06-11
• Last updated: 2018-01-03
• Results posted: 2014-12-22

Locations

1 site across 1 country: United States