CompletedNCT03252106Updated Aug 17, 2017

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

An interventional study of Contour augmentation with implant placement in Jaw, Edentulous, Partially, Dental Implants, Single-tooth and Grafting Bone, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-17.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 20 Years and older
Sex: All

Study 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.

Conditions studied

Jaw, Edentulous, Partially
Dental Implants, Single-tooth
Grafting Bone

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Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Heavy smoking (more than 10 cigarettes per day)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Contour augmentation
Procedure: Contour augmentation with implant placement

Interventions

ProcedureContour augmentation with implant placement
Contour augmentation with implant placement

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

University Hospital Inselspital
Bern, 3010, Switzerland

References and documents

Publications

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. PubMed 29073362 ↗

Registry details

Key details

Study ID: NCT03252106
Lead sponsor: University of Bern
Responsible party: Sponsor
First posted: Aug 17, 2017
Start date: Oct 10, 2016
Primary completion: Nov 10, 2016
Completion: Nov 10, 2016
Last update: Aug 17, 2017

Study contacts

Daniel Buser, DMD

study chair · University of Bern

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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