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OpenTrials
Enrolling by Invitation

NCT Number: NCT06185075

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

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

Enrolling by Invitation

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Key information

Conditions

Gum Disease Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Implant crown delivery

Procedure

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

Primary outcomes

  1. Marginal bone loss around dental implant

    Time frame: 6 months and 12 months after crown delivery

    Measured from radiographs in mm

  2. Gum tissue thickness

    Time frame: 6 months and 12 months after crown delivery

    Measured from intraoral scan in mm

  3. Gingival margin height

    Time frame: 6 months and 12 months after crown delivery

    Measured from intraoral scan in mm

  4. Amount of keratinized gingiva

    Time frame: 6 months and 12 months after crown delivery

    Measured clinically in mm

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2023
Registry last updated
Feb 12, 2026

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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