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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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06636097
Enrollment
50
Registered
2024-10-10
Start date
2024-06-11
Completion date
2027-12-01
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis

Keywords

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

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.

Interventions

DEVICEFull arch

design

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Probing Depth of the implantsThe 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 implantsThe 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 IndexThe 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 RecessionThe 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.
SuppurationThe 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 widthThe 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrea Ravida, DDS, MS, PhD

Program Director of the Periodontics and Implant Dentistry Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026