NCT01107600

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

April 19, 2010

Last Update Submit

August 15, 2018

Conditions

Dental Implants

Keywords

Dental Implants, Single-ToothBone RegenerationDental RestorationSocket preservation

Outcome Measures

Primary Outcomes (1)

  • Implant stability quote (ISQ) measurements.

    Measured by Ostell® Mentor Device.

    8 weeks

Secondary Outcomes (1)

  • Aesthetic Results and Patient Satisfaction

    1 year

Study Arms (1)

Nobel Active®

EXPERIMENTAL

Immediate implant and socket preservation

Procedure: Immediate implant and socket preservation

Interventions

Immediate implant and socket preservationPROCEDURE

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.

Nobel Active®

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Medical risk patient
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Marco Tallarico

Rome, 00151, Italy

Location

Odontoiatric center San Pietro Hospital, FBF

Rome, 00189, Italy

Location

Related Publications (1)

  • Atieh MA, Payne AG, Duncan WJ, Cullinan MP. Immediate restoration/loading of immediately placed single implants: is it an effective bimodal approach? Clin Oral Implants Res. 2009 Jul;20(7):645-59. doi: 10.1111/j.1600-0501.2009.01725.x.

    PMID: 19515058BACKGROUND

Study Officials

  • Marco Gargari, Professor

    San Pietro Hospital, FBF, Roma

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Immediate loading
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 19, 2010

First Posted

April 21, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

IT(2)