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Evaluation of the Stability of Implants With Two Different Surface Treatments

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ClinicalTrials.gov Identifier: NCT02134743
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Marcelo Michele Novellino, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Dental Implant Failed Pre-osseointegration Failure of Dental Implant Procedure: Implant surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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)




Primary Outcome Measures :
  1. Loss of implant [ Time Frame: 4 months after surgery ]
    If the implant has been not integrated to the bone!


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134743


Locations
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Brazil
Dentistry School - University of São Paulo
São Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Publications of Results:
Other Publications:
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Responsible Party: Marcelo Michele Novellino, PHD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02134743    
Other Study ID Numbers: 18911913.7.0000.0075
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Keywords provided by Marcelo Michele Novellino, University of Sao Paulo:
dental implant
Surface energy
Hydrophilicity
Contact angle
Titanium implant roughness
Surface conditioning