Intaglio Surface of Full-arch Implant Supported Prosthesis

• Conditions: Peri-Implantitis
• Interventions: Device: Full arch

• Registration Number: NCT06636097
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study Start: 2024-06-11
• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-10
• Last Update Posted: 2024-10-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Rehabilitated with full-arch implant-supported prosthesis	Full arch	All patients that are rehabilitated with full-arch implant-supported prosthesis

Primary Outcome Measures

Name	Time	Method
Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.	The measurements will be assessed during the unique visit of the patient in the study.	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.

Secondary Outcome Measures

Name	Time	Method
Probing Depth of the implants	The measurements will be assessed during the unique visit of the patient in the study.	Using a periodontal probe we will register Probing Depth in 6 sites per implant. All measures will be in mm.
Bleeding on Probing of the implants	The measurements will be assessed during the unique visit of the patient in the study.	Using a periodontal probe we will register Bleeding in 6 sites using the bleeding indexes modified for dental implants.
Modified Plaque Index	The measurements will be assessed during the unique visit of the patient in the study.	Plaque accumulation will be evaluated using the modified plaque index adapted for dental implants.
Marginal Recession	The measurements will be assessed during the unique visit of the patient in the study.	The distance, in mm, between the implant platform and the mucosal margin.
Suppuration	The measurements will be assessed during the unique visit of the patient in the study.	Assessed by the presence/absence of suppuration after gentle probing of the implants.
Keratinized mucosa width	The measurements will be assessed during the unique visit of the patient in the study.	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.

Trial Locations

Locations (1)

University of Pittsburgh, School of Dental Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States