Overview

This trial is active, not recruiting.

Condition edentulous jaws partially
Treatment rfa
Sponsor University of Sao Paulo
Start date February 2012
End date July 2013
Trial size 42 participants
Trial identifier NCT01699568, Erico1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Implants 4mm x 10mm Vulcano Actives (anodized surface)(AR Torque Vulcano actives), Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
rfa Osstell mentor
Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21
(Active Comparator)
Implants 4mm x 10mm Porous (dual acid-etched surface treatment)(AR Torque Porous, Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
rfa Osstell mentor
Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21

Primary Outcomes

Measure
implant loss
time frame: 4 months

Secondary Outcomes

Measure
ISQ analysis
time frame: 6 months

Eligibility Criteria

Male or female participants from 30 years up to 60 years old.

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.

Additional Information

Official title Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Principal investigator Érico Fraga Moreira, Master of Science
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Sao Paulo.