Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Michigan
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Gum tissue thickness
Study Overview
Brief Summary
This study will evaluate how the crown's shape under the gums will influence the gum tissue around dental implants.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Straight transmucosal contour
Implant crown will be designed with a straight transmucosal contour
Intervention: Implant crown delivery (Procedure)
Concave transmucosal contour
Implant crown will be designed with a concave transmucosal contour
Intervention: Implant crown delivery (Procedure)
Outcomes
Primary Outcomes
Gum tissue thickness
Time Frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Marginal bone loss around dental implant
Time Frame: 6 months and 12 months after crown delivery
Measured from radiographs in mm
Gingival margin height
Time Frame: 6 months and 12 months after crown delivery
Measured from intraoral scan in mm
Amount of keratinized gingiva
Time Frame: 6 months and 12 months after crown delivery
Measured clinically in mm
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Saleh
Clinical Assistant Professor, Periodontics and Oral Medicine
University of Michigan