Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Érico Castaldin Fraga Moreira, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01699568
First received: October 1, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Edentulous Jaws Partially
Device: RFA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • implant loss [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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:
  • ISQ analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 42
Study Start Date: February 2012
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Device: 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
Other Names:
  • Osstell mentor
  • resonance frequence analysis
Active Comparator: 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
Device: 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
Other Names:
  • Osstell mentor
  • resonance frequence analysis

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699568

Locations
Brazil
Faculdade de Odontologia da USP
São Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Érico Fraga Moreira, Master of Science Student of doctoral program
  More Information

No publications provided

Responsible Party: Érico Castaldin Fraga Moreira, Master of Science, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01699568     History of Changes
Other Study ID Numbers: Erico1
Study First Received: October 1, 2012
Last Updated: February 14, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
dental implant stability
dental implant surface treatment
resonance frequence analysis

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Mouth Diseases
Mouth, Edentulous
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 29, 2014