Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

NCT ID: NCT01699568

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29

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.

Conditions

Edentulous Jaws Partially

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Vulcano Actives

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

Group Type: EXPERIMENTAL

RFA

Intervention Type: DEVICE

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

Porous

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

Group Type: ACTIVE_COMPARATOR

RFA

Intervention Type: DEVICE

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

Interventions

RFA

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

Intervention Type: DEVICE

Other Intervention Names

Osstell mentor; resonance frequence analysis

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Érico Castaldin Fraga Moreira

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Érico Fraga Moreira, Master of Science

Role: PRINCIPAL_INVESTIGATOR

Student of doctoral program

Locations

Faculdade de Odontologia da USP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

Erico1

Identifier Type: -

Identifier Source: org_study_id