Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

University of Sao Paulo

Status: Unknown

Conditions: Edentulous Jaws Partially

Treatments: Device: RFA

Study type: Interventional

Funder types: Other

Identifiers

NCT01699568

Erico1

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Vulcano Actives

Experimental group

Description:

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

Treatment:

Device: RFA

Porous

Active Comparator group

Description:

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

Treatment:

Device: RFA