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NCT03252106 Clinical Trial

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

Jaw, Edentulous, Partially Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03252106
Other study ID # P004 Study
Secondary ID
Status Completed
Phase N/A
First received July 19, 2017
Last updated August 14, 2017
Start date October 10, 2016
Est. completion date November 10, 2016

Study information
Verified date August 2017
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date November 10, 2016
Est. primary completion date November 10, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Switzerland University Hospital Inselspital Bern

Sponsors (1)
Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of contour augmentation Measurement of facial bone wall width with cone beam CTs (in mm) 10 year examination
Secondary Esthetic examination Pink Esthetic Score 10 year examination
Secondary Peri-Implant soft tissue health Plaque Index 10 year examination
Secondary Peri-implant bone loss over time Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm 10 year examination
Secondary Peri-Implant soft tissue health Sulcus Bleeding Index 10 year examination
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