Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
NCT ID: NCT03558282
Last Updated: 2019-02-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
28 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-08-07
Study Completion Date
2019-01-22
Brief Summary
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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.
The primary outcome is to systematically evaluate the association of implant-, peri-implant tissue-, and restoration-related factors with facial mucosal level changes.
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Detailed Description
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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.
Conditions
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Gingival Recession
Study Design
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Observational Model Type
COHORT
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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Maxillary Anterior Implant
Subjects who have a single implant restoration in the maxillary anterior position with sufficient baseline data. Recession observation and crown contour observation of the implant will be completed.
Recession Observation
Intervention Type
OTHER
Soft tissue measurements
Crown Contour Observation
Intervention Type
DIAGNOSTIC_TEST
Ultrasound measures of implant crown contour.
Interventions
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Recession Observation
Soft tissue measurements
Intervention Type
OTHER
Crown Contour Observation
Ultrasound measures of implant crown contour.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Kuwait Foundation for the Advancement of Sciences
UNKNOWN
Sponsor Role
collaborator
University of Michigan
OTHER
Sponsor Role
lead
Responsible Party
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Hsun-Liang Chan
Clinical Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Hsun-Liang Chan, DDS, MS
Role: PRINCIPAL_INVESTIGATOR
Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
Locations
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University of Michigan School of Dentistry
Ann Arbor, Michigan, United States
Site Status
Countries
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United States
References
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Other Identifiers
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HUM00139630
Identifier Type: -
Identifier Source: org_study_id
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