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Study on Immediate Loading of Immediately Placed Single Implants.

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ClinicalTrials.gov Identifier: NCT01107600
Recruitment Status : Unknown
Verified April 2010 by Hospital San Pietro Fatebenefratelli.
Recruitment status was:  Not yet recruiting
First Posted : April 21, 2010
Last Update Posted : April 21, 2010
Sponsor:
Collaborators:
Nobel Biocare
Geistlich Pharma AG
Information provided by:
Hospital San Pietro Fatebenefratelli

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.

Condition or disease Intervention/treatment Phase
Dental Implants Procedure: Immediate implant and socket preservation Not Applicable

Detailed Description:

The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges.

The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.
Study Start Date : June 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nobel Active®
Dental implant
 Procedure: Immediate implant and socket preservation
Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.
Active Comparator: Bio-oss® biomaterial
Dental biomaterial
 Procedure: Immediate implant and socket preservation
Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.


Outcome Measures
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Primary Outcome Measures :
  1. Implant stability quote (ISQ) measurements. [ Time Frame: 8 weeks ]
    Measured by Ostell® Mentor Device.


Secondary Outcome Measures :
  1. Aesthetic Results and Patient Satisfaction [ Time Frame: 1 year ]
    Bone crest level changes measured by standardized intraoral radiographs.


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Single-tooth implant restorations in the aesthetic zone

Exclusion Criteria:

  • Medical risk patient
  • Smoking
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01107600


Contacts
Contact: Marco Tallarico, doctor 0039 3280758769 marco.tallarico@fastwebnet.it

Locations
Italy
Marco Tallarico Not yet recruiting
Rome, Italy, 00151
Contact: Marco Tallarico, Doctor    0039 3280758769    marco.tallarico@fastwebnet.it   
Sub-Investigator: Marco Tallarico, Doctor         
Odontoiatric center San Pietro Hospital, FBF Not yet recruiting
Rome, Italy, 00189
Contact: Gargari Marco, Doctor    0039 3356588202    marco.gargari@gmail.com   
Principal Investigator: Tallarico Marco, Doctor         
Sub-Investigator: Francesco Ceruso, Doctor         
Sponsors and Collaborators
Hospital San Pietro Fatebenefratelli
Nobel Biocare
Geistlich Pharma AG
Investigators
Study Director: Marco Gargari, Professor San Pietro Hospital, FBF, Roma
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Marco Tallarico, Odontoiatric Center, San Pietro Hospital, Fatebenefratelli (FBF)
ClinicalTrials.gov Identifier: NCT01107600     History of Changes
Other Study ID Numbers: HSPFBF-NB-02
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: April 21, 2010
Last Verified: April 2010

Keywords provided by Hospital San Pietro Fatebenefratelli:
Dental Implants, Single-Tooth
Bone Regeneration
Dental Restoration
Socket preservation