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Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

Stability of Implants With Different Surface Treatment: Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01699568
Enrollment
42
Registered
2012-10-03
Start date
2012-02-29
Completion date
Unknown
Last updated
2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Jaws Partially

Keywords

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

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.

Interventions

DEVICERFA

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
implant loss4 monthsDuring 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

MeasureTime frameDescription
ISQ analysis6 monthsSince 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026