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OpenTrials
Completed

NCT Number: NCT03558282

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recession Observation

Other

Soft tissue measurements

Crown Contour Observation

Diagnostic Test

Ultrasound measures of implant crown contour.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Kuwait Foundation for the Advancement of Sciences

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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