Skip to main content
Clinical Trials/NCT02134743
NCT02134743
Completed
Not Applicable

Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial

University of Sao Paulo1 site in 1 country21 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implant Failed
Sponsor
University of Sao Paulo
Enrollment
21
Locations
1
Primary Endpoint
Loss of implant
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.

Detailed Description

The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols. The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcelo Michele Novellino

PHD Student

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
  • Able to understand and sign a waiver of informed free consent
  • Good oral hygiene
  • The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.

Exclusion Criteria

  • Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
  • Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.

Outcomes

Primary Outcomes

Loss of implant

Time Frame: 4 months after surgery

If the implant has been not integrated to the bone!

Secondary Outcomes

  • Implant stability (ISQ)(Baseline, 1 to 16 weeks (4 months))

Study Sites (1)

Loading locations...

Similar Trials