Intaglio Surface of Full-arch Implant Supported Prosthesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-11

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine if there is an association between the intaglio shape of full-arch implant-supported prosthesis and marginal bone level around implants. The intaglio shape can be present as concave or convex and, depending on that, it can lead to more plaque accumulation on the fitting surface of the prosthesis.

Null Hypothesis (H0): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate similar marginal bone levels as prosthesis with a reduced depth of the intaglio surface.

Alternative Hypothesis (H1): Full-arch implant supported prosthesis with an increased depth of the intaglio shape demonstrate increased/reduced marginal bone levels compared to prosthesis with a reduced depth of the intaglio surface.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Peri-implant Bone Formation of Grafted Sites Around Hydrophilic and Non-hydrophilic Dental Implants

NCT06460103

Partially Edentulous Maxilla Partially Edentulous Mandible

NOT_YET_RECRUITING NA

Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)

NCT01623739

Jaw, Edentulous, Partially Acquired Absence of Single Tooth

COMPLETED NA

Platform Switched Implant and Bone Level Alteration

NCT02867982

Edentulous Bone Resorption

UNKNOWN NA

Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments

NCT04369170

Periimplant Bone Loss Marginal Periimplant Bone Level Periimplantitis

UNKNOWN NA

Marginal Bone Remodeling at Monolithic Zirconia Full-Arch Prostheses in the Maxilla and Mandible

NCT07323290

Edentulism Implant Dentistry

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The investigators will review dental records from the university and call eligible individuals for an appointment. During the research visit, the investigators will take new x-rays for marginal bone level assessment and a digital scan of the prosthesis to assess the shape of the intaglio. Also, remove the prosthesis, perform clinical measurements and collect plaque samples from the prosthesis and the implant sulcus. then, implants and prosthesis will be cleaned and placed in position.

The study will have only one appointment where every measurement will be assessed in this visit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-Implantitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients Rehabilitated with full-arch implant-supported prosthesis

All patients that are rehabilitated with full-arch implant-supported prosthesis

Full arch

Intervention Type DEVICE

design

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Full arch

design

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 18 years old;
* Rehabilitated with a full-arch screw-retained supported prosthesis in the maxilla, in function for at least 1 year;
* Good overall health (ASA I or ASA II).

Exclusion Criteria

* Individuals with motricity problems who cannot clean the prosthesis;
* Patients treated or maintained in centers outside the University of Pittsburgh;
* Incomplete dental records;
* Misfit at the prosthesis-implant interface;
* Cemented prosthesis;
* Individuals rehabilitated with over dentures;
* Individuals with uncontrolled chronic diseases or immunocompromised;
* Pregnant Patients.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes