Intaglio Surface of Full-arch Implant Supported Prosthesis

University of Pittsburgh

Status: Invitation-only

Conditions: Peri-Implantitis

Treatments: Device: Full arch

Study type: Observational

Funder types: Other

Identifiers

NCT06636097

STUDY23100028

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Patients Rehabilitated with full-arch implant-supported prosthesis

Description:

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

Treatment:

Device: Full arch