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

October 1, 2012
February 14, 2013
February 2012
July 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01699568 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Edentulous Jaws Partially
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
  • 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
    Intervention: Device: RFA
  • 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
    Intervention: Device: RFA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
42
Not Provided
July 2013   (final data collection date for primary outcome measure)

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.
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01699568
Erico1
No
Érico Castaldin Fraga Moreira, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Érico Fraga Moreira, Master of Science Student of doctoral program
University of Sao Paulo
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP