Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes

February 9, 2026 updated by: Muhammad Saleh, University of Michigan
This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This research is studying the transmucosal contour, or shape of crowns (white-colored tooth structure that sits above the gum) under the gums on dental implants. Participants will be randomly selected for the dental implant crown to be designed with either a straight or concave transmucosal contour, and followed up on for 1 year after crown delivery.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria

  • Be a current participant of HUM00208140 main study
  • Have a dental implant that is ready to be restored (placed at least 3 months ago and healing is adequate)

Exclusion Criteria:

• The dental implant crown was already delivered.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Straight transmucosal contour
Implant crown will be designed with a straight transmucosal contour
Procedure: Implant crown delivery
Dental implant crown will be designed, fabricated by a dental lab, and delivered.
Active Comparator: Concave transmucosal contour
Implant crown will be designed with a concave transmucosal contour
Procedure: Implant crown delivery
Dental implant crown will be designed, fabricated by a dental lab, and delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal bone loss around dental implant
Time Frame: 6 months and 12 months after crown delivery
Measured from radiographs in mm
6 months and 12 months after crown delivery
Gum tissue thickness
Time Frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
6 months and 12 months after crown delivery
Gingival margin height
Time Frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
6 months and 12 months after crown delivery
Amount of keratinized gingiva
Time Frame: 6 months and 12 months after crown delivery
Measured clinically in mm
6 months and 12 months after crown delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Muhammad Saleh, BDS, MSD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 29, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00208140 Substudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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