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
Recruitment status was Not yet recruiting
Sponsor:
Hospital San Pietro Fatebenefratelli
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
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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 (Adult, Senior) |
| 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
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 September 23, 2016