Study on Immediate Loading of Immediately Placed Single Implants.

August 15, 2018 updated by: Marco Tallarico, Hospital San Pietro Fatebenefratelli

Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

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

  • Italy
      • Rome, Italy, 00151
        • Marco Tallarico
      • Rome, Italy, 00189
        • Odontoiatric center San Pietro Hospital, FBF

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Medical risk patient
  • Smoking

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nobel Active®
Immediate implant and socket preservation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability quote (ISQ) measurements.
Time Frame: 8 weeks
Measured by Ostell® Mentor Device.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aesthetic Results and Patient Satisfaction
Time Frame: 1 year
Bone crest level changes measured by standardized intraoral radiographs.
1 year

Collaborators and Investigators

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

Sponsor

Hospital San Pietro Fatebenefratelli

Collaborators

Geistlich Pharma AG
Nobel Biocare

Investigators

  • Study Director: Marco Gargari, Professor, San Pietro Hospital, FBF, Roma

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 (Anticipated)

June 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSPFBF-NB-02

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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