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

Gum Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06185075
• Other study ID #: HUM00208140 Substudy
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 28, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• Gum Disease
• Periodontal Diseases

Intervention

Procedure:
• Implant crown delivery
Dental implant crown will be designed, fabricated by a dental lab, and delivered.

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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