Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
This trial is active, not recruiting.
|Condition||edentulous jaws partially|
|Sponsor||University of Sao Paulo|
|Start date||February 2012|
|End date||July 2013|
|Trial size||42 participants|
|Trial identifier||NCT01699568, Erico1|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
|Primary purpose||basic science|
time frame: 4 months
time frame: 6 months
Male or female participants from 30 years up to 60 years old.
- 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.
- 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.
|Official title||Stability of Implants With Different Surface Treatment: Randomized Clinical Trial|
|Principal investigator||Érico Fraga Moreira, Master of Science|
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