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

NCT ID: NCT06185075

Last Updated: 2026-02-12

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2026-12-01

Brief Summary

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This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.

Detailed Description

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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.

Conditions

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Gum Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Straight transmucosal contour

Implant crown will be designed with a straight transmucosal contour

Group Type ACTIVE_COMPARATOR

Implant crown delivery

Intervention Type PROCEDURE

Dental implant crown will be designed, fabricated by a dental lab, and delivered.

Concave transmucosal contour

Implant crown will be designed with a concave transmucosal contour

Group Type ACTIVE_COMPARATOR

Implant crown delivery

Intervention Type PROCEDURE

Dental implant crown will be designed, fabricated by a dental lab, and delivered.

Interventions

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Implant crown delivery

Dental implant crown will be designed, fabricated by a dental lab, and delivered.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Saleh

Clinical Assistant Professor, Periodontics and Oral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Saleh, BDS, MSD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

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

Other Identifiers

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HUM00208140 Substudy

Identifier Type: -

Identifier Source: org_study_id

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