Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Primary Purpose
Edentulous Jaws Partially
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
RFA
Sponsored by
About this trial
This is an interventional basic science trial for Edentulous Jaws Partially focused on measuring dental implant stability, dental implant surface treatment, 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.
Sites / Locations
- Faculdade de Odontologia da USP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vulcano Actives
Porous
Arm 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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
ISQ analysis
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
Full Information
NCT ID
NCT01699568
First Posted
October 1, 2012
Last Updated
February 14, 2013
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01699568
Brief Title
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Official Title
Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaws Partially
Keywords
dental implant stability, dental implant surface treatment, resonance frequence analysis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vulcano Actives
Arm Type
Experimental
Arm 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
Arm Title
Porous
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
RFA
Other Intervention Name(s)
Osstell mentor, resonance frequence analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
implant loss
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
ISQ analysis
Description
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
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Érico Fraga Moreira, Master of Science
Organizational Affiliation
Student of doctoral program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Odontologia da USP
City
São Paulo
ZIP/Postal Code
05508-000
Country
Brazil
12. IPD Sharing Statement
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Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
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