Intaglio Surface of Full-arch Implant Supported Prosthesis

Effect of the Intaglio Surface of Full-arch Implant-supported on Marginal Bone Level: A Cross-sectional Study

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peri-Implantitis
• Intervention / Treatment: Device: Full arch

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients Rehabilitated with full-arch implant-supported prosthesis; All patients that are rehabilitated with full-arch implant-supported prosthesis	Device: Full arch; design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing Depth of the implants	Using a periodontal probe we will register Probing Depth in 6 sites per implant. All measures will be in mm.	The measurements will be assessed during the unique visit of the patient in the study.
Bleeding on Probing of the implants	Using a periodontal probe we will register Bleeding in 6 sites using the bleeding indexes modified for dental implants.	The measurements will be assessed during the unique visit of the patient in the study.
Modified Plaque Index	Plaque accumulation will be evaluated using the modified plaque index adapted for dental implants.	The measurements will be assessed during the unique visit of the patient in the study.
Marginal Recession	The distance, in mm, between the implant platform and the mucosal margin.	The measurements will be assessed during the unique visit of the patient in the study.
Suppuration	Assessed by the presence/absence of suppuration after gentle probing of the implants.	The measurements will be assessed during the unique visit of the patient in the study.
Keratinized mucosa width	Measured from the mucosal marginal level of the implants to the mucogingival junction. The band of keratinized mucosa will be characterized as narrow < 2mm and wide > 2mm.	The measurements will be assessed during the unique visit of the patient in the study.

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Andrea Ravida, DDS, MS, PhD, Program Director of the Periodontics and Implant Dentistry Department

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Estimated): October 10, 2025
• Last Update Submitted That Met QC Criteria: October 8, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Peri-implantitis; Dental Implants; Hybrid prosthesis; Marginal Bone Level; Full-arch Prosthesis
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Peri-Implantitis
• Other Study ID Numbers: STUDY23100028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No