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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03558282
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Kuwait Foundation for the Advancement of Sciences
Information provided by (Responsible Party):
Hsun-Liang Chan, University of Michigan

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Gingival Recession Other: Recession Observation Diagnostic Test: Crown Contour Observation

Detailed Description:
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.
Study Design
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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Facial Mucosal Level Determinants for Single Immediately Placed Implants Evaluated by Novel Ultrasonography
Actual Study Start Date : August 7, 2018
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Recession Observation
Soft tissue measurements

Diagnostic Test: Crown Contour Observation
Ultrasound measures of implant crown contour.


Outcome Measures
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Primary Outcome Measures :
  1. Mucosal recession on the tested implant [ Time Frame: At least 12 months following implant placement. ]
    It is a one-time measurement (this study is only one-time visit) within the study timeframe, measured from a reference, adjacent tooth landmark, to the mucosal margin of the implant.


Secondary Outcome Measures :
  1. Crown contour of the tested implant [ Time Frame: At least 12 months following implant placement. ]
    It is a one-time measurement (this study is only one-time visit) within the study timeframe. It is measured on ultrasound images. It is the angle between the tangent line of the implant crown and implant fixture.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who had a single implant restoration in the maxillary anterior position with sufficient baseline data will be recruited for this study.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558282


Locations
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United States, Michigan
University of Michigan School of Dentistry
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Kuwait Foundation for the Advancement of Sciences
Investigators
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Principal Investigator: Hsun-Liang Chan, DDS, MS Department of Periodontics and Oral Medicine University of Michigan School of Dentistry
More Information
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Publications:

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Responsible Party: Hsun-Liang Chan, Clinical Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03558282    
Other Study ID Numbers: HUM00139630
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
 Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy