Influence of Implant Crown Transmucosal Contour Design on Soft and Hard Tissue Clinical Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Implant crown delivery.
- Who it may be relevant to
- Registry conditions: Gum Disease. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Implant crown delivery
Dental implant crown will be designed, fabricated by a dental lab, and delivered.
Primary outcome measures
- Marginal bone loss around dental implant [Time frame: 6 months and 12 months after crown delivery]
- Gum tissue thickness [Time frame: 6 months and 12 months after crown delivery]
- Gingival margin height [Time frame: 6 months and 12 months after crown delivery]
- Amount of keratinized gingiva [Time frame: 6 months and 12 months after crown delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan School of Dentistry — Ann Arbor
Identifiers
NCT: NCT06185075 · HUM00208140 Substudy