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Clinical Trials/NCT03915509
NCT03915509
Completed
Not Applicable

Evaluation Of The Effect Of Surface Properties On The Stabılıty Of The Different Implants With Resonance Frequency Analysis

Aydin Adnan Menderes University1 site in 1 country50 target enrollmentApril 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implantation
Sponsor
Aydin Adnan Menderes University
Enrollment
50
Locations
1
Primary Endpoint
Survey
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This randomised clinical study aims to evaluate different surfaced implants (alkali-modified surfaced implants or sand-blasted surfaced implants) stability with resonance frequency analysis(RFA).

Detailed Description

This is randomised controlled double blind study. Fourteen patients (8 women and 6 men;age 43.7 ± 8.56 years) who were attending the Oral and Maxillofacial Surgery Department and scheduled for implant placement surgery were included in this study. Dental implants were placed using one-stage protocol. After adminstration of local anesthesia (Ultracain DS; Aventis Pharmaceuticals, Istanbul, Turkey ), an incision was made on the alveolar ridge. A total of 50 implants (Impladent implants from the Lasak) were placed in the not site assignement mandibular premolar/molar sites according to the manufacturer's instructions. To prevent bias which implant to the right or left to make the decision investigators decided by envelope. The person making the measurement does not know which surface implant is made to the patient. An equal number of implants were applied simultaneously with different surfaces. The patient does not know where the implant is placed. All used implants were 3.7 width, 10mm. height and same design for standardization this study. Investigators obtained good primarly stability and placed a healing cap for 45 implants . 3 sandblasted and acid-and alkali-treated surface straight (bioactive)implants and 2 sandblasted surface straight implants were excluded in this study for bad primary stability. Investigators used to measure implant stability with Osstell ISQ ( Integration diagnostic AB, Savedalen, Sweden) for each implant at the time of surgery before flap closure, 2. week,6. week and 12. week postoperatively.This device was used in both buccolingual and mesiodistal direction. The Smartpegs (Integration Diagnostics AB, Göteborg, Sweden) were compressed and the measurements were performed by the same surgeon for standardization of the stability measurements. The measurements were taken twice in the buccolingual direction and twice in the mesiodistal direction. The arithmetic mean of the 2 measurements from each direction was regarded as the representative ISQ of that implant. In addition, each implant was clinically evaluated at all visits for mobility, pain, and signs of infection.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
March 2012
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Aydin Adnan Menderes University
Responsible Party
Principal Investigator
Principal Investigator

Burcu Gürsoytrak

Assistant Proffesor

Aydin Adnan Menderes University

Eligibility Criteria

Inclusion Criteria

  • 1.A healthy medical condition (ASA 1 and ASA 2 according to the American Society of Anesthesiologists classification) 2.The ability to withstand the stress of dental implant surgery 3.The need for bilateral implant-supported rehabilitation in the mandibular premolar/molar area.

Exclusion Criteria

  • An active infection or severe inflammation in the areas intended for implant placement
  • Metabolic bone disorder
  • Uncontrolled diabetes
  • Hematologic disorder
  • Need for bone augmentation
  • The smokers
  • Drug users (anti-inflammatory agents, bisphosphonates)
  • Pregnant patients

Outcomes

Primary Outcomes

Survey

Time Frame: 3 months

Defined after clinical and radiological examination.

Secondary Outcomes

  • Surgery Implant Stability Quotient Measurement(3 months)
  • Second Implant Stability Quotient Measurement(3 months)
  • Third Implant Stability Quotient Measurement(3 months)
  • Fourth Implant Stability Quotient Measurement(3 months)

Study Sites (1)

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