NCT06185075

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 28, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

2.6 years

First QC Date

December 14, 2023

Last Update Submit

February 9, 2026

Conditions

Gum Disease

Outcome Measures

Primary Outcomes (4)

  • Marginal bone loss around dental implant

    Measured from radiographs in mm

    6 months and 12 months after crown delivery

  • Gum tissue thickness

    Measured from intraoral scan in mm

    6 months and 12 months after crown delivery

  • Gingival margin height

    Measured from intraoral scan in mm

    6 months and 12 months after crown delivery

  • Amount of keratinized gingiva

    Measured clinically in mm

    6 months and 12 months after crown delivery

Study Arms (2)

Straight transmucosal contour

ACTIVE COMPARATOR

Implant crown will be designed with a straight transmucosal contour

Procedure: Implant crown delivery

Concave transmucosal contour

ACTIVE COMPARATOR

Implant crown will be designed with a concave transmucosal contour

Procedure: Implant crown delivery

Interventions

Implant crown deliveryPROCEDURE

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

Concave transmucosal contourStraight transmucosal contour

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • The dental implant crown was already delivered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Muhammad Saleh, BDS, MSD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor, Periodontics and Oral Medicine

Study Record Dates

First Submitted

December 14, 2023

First Posted

December 29, 2023

Study Start

November 28, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)