Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

NCT01699568 | Unknown

• 1 other identifier: Erico1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

dental implant stability; dental implant surface treatment; resonance frequence analysis

Outcome Measures

Primary Outcomes (1)

• implant loss

  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

  4 months

Secondary Outcomes (1)

• ISQ analysis

  6 months

Study Arms (2)

Vulcano Actives

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

Device: RFA

Porous

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

Device: RFA

Interventions

RFA 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

Also known as: Osstell mentor, resonance frequence analysis

Porous; Vulcano Actives

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Faculdade de Odontologia da USP

São Paulo, São Paulo, 05508-000, Brazil

Location

Study Officials

• Érico Fraga Moreira, Master of Science

  Student of doctoral program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

BR (1)