Clinical trial NCT06636097: Intaglio Surface of Full-arch Implant Supported Prosthesis
Official title: Effect of the Intaglio Surface of Full-arch Implant-supported on Marginal Bone Level: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peri-Implantitis
Keywords: Peri-implantitis
Marginal Bone Level
Dental Implants
Full-arch Prosthesis
Hybrid prosthesis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level.
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
Secondary outcomes:
measure: Probing Depth of the implants
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
measure: Bleeding on Probing of the implants
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
measure: Modified Plaque Index
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
measure: Marginal Recession
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
measure: Suppuration
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
measure: Keratinized mucosa width
timeFrame: The measurements will be assessed during the unique visit of the patient in the study.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: Program Director of the Periodontics and Implant Dentistry Department
name: Andrea Ravida, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424.