Study on Immediate Loading of Immediately Placed Single Implants.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Hospital San Pietro Fatebenefratelli.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Nobel Biocare
Geistlich Pharma AG
Information provided by:
Hospital San Pietro Fatebenefratelli
ClinicalTrials.gov Identifier:
NCT01107600
First received: April 19, 2010
Last updated: April 20, 2010
Last verified: April 2010
  Purpose

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 Intervention
Dental Implants
Procedure: Immediate implant and socket preservation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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®.

Further study details as provided by Hospital San Pietro Fatebenefratelli:

Primary Outcome Measures:
  • Implant stability quote (ISQ) measurements. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Measured by Ostell® Mentor Device.


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


Estimated Enrollment: 10
Study Start Date: June 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received: April 19, 2010
Last Updated: April 20, 2010
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 25, 2014