Back to resultsLong-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
Primary Purpose
Jaw, Edentulous, Partially, Dental Implants, Single-tooth, Grafting Bone
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Contour augmentation with implant placement
Sponsored by
About this trial
This is an interventional treatment trial for Jaw, Edentulous, Partially
Eligibility Criteria
Inclusion Criteria:
- Single tooth gaps post extraction in the esthetic zone
- Written informed consent
Exclusion Criteria:
- Heavy smoking (more than 10 cigarettes per day)
Sites / Locations
- University Hospital Inselspital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contour augmentation
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of contour augmentation
Measurement of facial bone wall width with cone beam CTs (in mm)
Secondary Outcome Measures
Esthetic examination
Pink Esthetic Score
Peri-Implant soft tissue health
Plaque Index
Peri-implant bone loss over time
Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm
Peri-Implant soft tissue health
Sulcus Bleeding Index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03252106
Brief Title
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
Official Title
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
November 10, 2016 (Actual)
Study Completion Date
November 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially, Dental Implants, Single-tooth, Grafting Bone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contour augmentation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Contour augmentation with implant placement
Intervention Description
Contour augmentation with implant placement
Primary Outcome Measure Information:
Title
Effectiveness of contour augmentation
Description
Measurement of facial bone wall width with cone beam CTs (in mm)
Time Frame
10 year examination
Secondary Outcome Measure Information:
Title
Esthetic examination
Description
Pink Esthetic Score
Time Frame
10 year examination
Title
Peri-Implant soft tissue health
Description
Plaque Index
Time Frame
10 year examination
Title
Peri-implant bone loss over time
Description
Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm
Time Frame
10 year examination
Title
Peri-Implant soft tissue health
Description
Sulcus Bleeding Index
Time Frame
10 year examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Single tooth gaps post extraction in the esthetic zone
Written informed consent
Exclusion Criteria:
Heavy smoking (more than 10 cigarettes per day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Buser, DMD
Organizational Affiliation
University of Bern
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29073362
Citation
Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.
Results Reference
derived
Learn more about this trial
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
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