Intaglio Surface of Full-arch Implant Supported Prosthesis

NCT06636097 | Enrolling By Invitation

• 1 other identifier: STUDY23100028
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis

Keywords

Peri-implantitis; Marginal Bone Level; Dental Implants; Full-arch Prosthesis; Hybrid prosthesis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.

  After the prosthesis is scanned, and evaluation of the 3D file of the prosthesis will occur. A virtual line will be traced between the Buccal to the Palatal/Lingual flange of the prosthesis. In the middle point of this line, a perpendicular line will be traced in direction of the fitting surface of the prosthesis, intaglio, and this distance will be measured in mm.

  The measurements will be assessed during the unique visit of the patient in the study.

Secondary Outcomes (6)

• Probing Depth of the implants

  The measurements will be assessed during the unique visit of the patient in the study.

• Bleeding on Probing of the implants

  The measurements will be assessed during the unique visit of the patient in the study.

• Modified Plaque Index

  The measurements will be assessed during the unique visit of the patient in the study.

• Marginal Recession

  The measurements will be assessed during the unique visit of the patient in the study.

• Suppuration

  The measurements will be assessed during the unique visit of the patient in the study.

Study Arms (1)

Patients Rehabilitated with full-arch implant-supported prosthesis

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

Device: Full arch

Interventions

Full arch DEVICE

design

Patients Rehabilitated with full-arch implant-supported prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with a full-arch implant-supported prothesis from the University of Pittsburgh will be screened for inclusion in the study.

You may qualify if:

• ≥ 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh, School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

  PMID: 3507627 RESULT

• Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424.

  PMID: 29926949 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial collection will be collected from the implant sulcus and from the abutments of the prosthesis.

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andrea Ravida, DDS, MS, PhD

  Program Director of the Periodontics and Implant Dentistry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)