Evaluation of the Stability of Implants With Two Different Surface Treatments

September 15, 2016 updated by: Marcelo Michele Novellino, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-000
        • Dentistry School - University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
At this group the patients will receive dental implants which have a modified SLA surface. These surface have wettability, which could improve and accelerate the osseointegration.Intervention: implant placement.
Procedure: Implant surgery
Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)
Other Names:
  • Neodent Neoporos (SLA surface)
  • Neodent Acqua (Modified SLA surface)
Active Comparator: Control Group
The patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement.
Procedure: Implant surgery
Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)
Other Names:
  • Neodent Neoporos (SLA surface)
  • Neodent Acqua (Modified SLA surface)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loss of implant
Time Frame: 4 months after surgery
If the implant has been not integrated to the bone!
4 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability (ISQ)
Time Frame: Baseline, 1 to 16 weeks (4 months)
If the implant get successively and it has been integrated to bone. The stability will be evaluated at the surgery day (T0), one week after surgery (T1),after 2 weeks (T2), after 3 weeks (T3), after 5 weeks (T4), after 8 weeks (T5), after 12 weeks (T6) and after 16 weeks (T7).
Baseline, 1 to 16 weeks (4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 4, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18911913.7.0000.0075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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