Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

Not Applicable

• Conditions: Edentulous Jaws Partially
• Interventions: Device: RFA

• Registration Number: NCT01699568
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15
• Primary Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vulcano Actives	RFA	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
Porous	RFA	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

Primary Outcome Measures

Name	Time	Method
implant loss	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 Outcome Measures

Name	Time	Method
ISQ analysis	6 months	Since the implant installation, for the next 8 weeks, and after for the next 4 months, the implant stability will be measure with the Osstell, that will return a number between 0 and 100. This represents the Implant Stability Quotient (ISQ). The difference between the ISQ results will be the secondary outcome measure

Trial Locations

Locations (1)

Faculdade de Odontologia da USP; 🇧🇷 São Paulo, Brazil