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

NCT03558282 | Completed

• 1 other identifier: HUM00139630
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Mucosal recession on the tested implant

  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.

  At least 12 months following implant placement.

Secondary Outcomes (1)

• Crown contour of the tested implant

  At least 12 months following implant placement.

Study Arms (1)

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; Diagnostic Test: Crown Contour Observation

Interventions

Recession Observation OTHER

Soft tissue measurements

Maxillary Anterior Implant

Crown Contour Observation DIAGNOSTIC_TEST

Ultrasound measures of implant crown contour.

Maxillary Anterior Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Kuwait Foundation for the Advancement of Sciences: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (44)

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MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Hsun-Liang Chan, DDS, MS

  Department of Periodontics and Oral Medicine University of Michigan School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 15, 2018
• Study Start: August 7, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)