Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:August 7, 2018
End Date:January 22, 2019

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A single center, prospective clinical trial is planned to investigate the effect of different
emergence angles of implant restorations on peri-implant soft tissue recession and implant
marginal bone loss.

The primary outcome is to systematically evaluate the association of implant-, peri-implant
tissue-, and restoration-related factors with facial mucosal level changes.

Facial mucosal recession still poses a threat to long-term success of implant therapy
especially esthetic appearance. To study the timing and extent of mucosal recession and the
associated risks, a prospective study is strategically important. This will allow the
collection of valuable longitudinal data about facial mucosal level changes, peri-implant
tissue dimensions, and implant/restoration parameters that are considered critical for
determining the mucosal level. Forty adult patients who meet the inclusion criteria will be
recruited to participate in this study. Patients that had an implant crown placed a minimum
time frame of 6 months and have existing relevant clinical data (mucosal level and thickness,
radiographs, cone beam computed tomogram (CBCT) scans, study casts and intra-oral
photographs) at baseline and if possible at other follow-up visits will be invited to
participate in this study. Patients that volunteer to be screened will not be examined for
study eligibility until an informed consent has been obtained. Patient information will be
protected according to HIPAA. The enrolled subjects will have research measurements taken, an
ultrasound scan, intraoral photos and an impression of the arch including the study implant.
One dental cone beam computed tomography (CBCT) scan will be taken to evaluate the implant
position in relation to the alveolar ridge and to evaluate relative bone quality. The primary
outcome will analyze the changes in the facial mucosal level, by superimposing the digital
images of the stone models that were taken previously. On ultrasound images, peri-implant
tissue parameters, implant positions, restoration contour, etc., will be measured and
recorded. The primary outcome will then be equated with clinical and radiographic readings,
and ultrasound parameters, along with timing of provisionalization or final restoration, in
regression analysis to identify factors related to facial mucosal recession.

Inclusion Criteria:

- Subjects 18 years old or older

- One immediate maxillary implant placement with 2 adjacent neighboring teeth

- Available pre-surgery model

- Radiographic documentation (either peri-apical x-rays or CBCT)

- Have final restoration for at least 6 months.

Exclusion Criteria:

- Are under 18 years of age.

- Are unwilling or unable to read and sign this informed consent document.

- Have any medical conditions that we believe may influence the outcome of the study.
We found this trial at
1
site
Ann Arbor, Michigan 48109
Phone: 734-763-9539
?
mi
from
Ann Arbor, MI
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