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Clinical Trials/NCT01699568
NCT01699568
Unknown
Not Applicable

Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

University of Sao Paulo1 site in 1 country42 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Edentulous Jaws Partially
Sponsor
University of Sao Paulo
Enrollment
42
Locations
1
Primary Endpoint
implant loss
Last Updated
13 years ago

Overview

Brief Summary

Objectives: To compare the stability of implant surface treated by dual acid etching (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after installation.

Methods: it will be a clinical study with individuals with missing teeth requiring rehabilitation with dental implants in the maxilla and that fulfill the study inclusion criteria. The research sites will be randomized into two groups: the control group patient's sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive statistics and comparative.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
July 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Érico Castaldin Fraga Moreira

Master of Science

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • patients who have missing teeth in the maxilla,
  • over 30 years old and under 60 years old,
  • the implant sites with at least 3 months of healing after extraction,
  • the implant sites with width and length to installation of an implant of 4 mm x 10 mm.

Exclusion Criteria

  • patients who experience any of the following conditions:
  • general contraindications for surgical procedures,
  • uncontrolled diabetes,
  • severe bruxism or clenching,
  • pregnant and lactating women,
  • active periodontal disease,
  • smoker and user of alcohol or drugs.

Outcomes

Primary Outcomes

implant loss

Time Frame: 4 months

During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost

Secondary Outcomes

  • ISQ analysis(6 months)

Study Sites (1)

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