Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement

August 14, 2017 updated by: University of Bern
In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Inselspital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single tooth gaps post extraction in the esthetic zone
  • Written informed consent

Exclusion Criteria:

  • Heavy smoking (more than 10 cigarettes per day)

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: Contour augmentation
Procedure: Contour augmentation with implant placement
Contour augmentation with implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of contour augmentation
Time Frame: 10 year examination
Measurement of facial bone wall width with cone beam CTs (in mm)
10 year examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Esthetic examination
Time Frame: 10 year examination
Pink Esthetic Score
10 year examination
Peri-Implant soft tissue health
Time Frame: 10 year examination
Plaque Index
10 year examination
Peri-implant bone loss over time
Time Frame: 10 year examination
Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm
10 year examination
Peri-Implant soft tissue health
Time Frame: 10 year examination
Sulcus Bleeding Index
10 year examination

Collaborators and Investigators

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

Sponsor

University of Bern

Investigators

  • Study Chair: Daniel Buser, DMD, University of Bern

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 (Actual)

October 10, 2016

Primary Completion (Actual)

November 10, 2016

Study Completion (Actual)

November 10, 2016

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P004 Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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