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Enrolling by invitation NCT06636097

Intaglio Surface of Full-arch Implant Supported Prosthesis

— Observational Peri-Implantitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Full arch.
Who it may be relevant to
Registry conditions: Peri-Implantitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Device Full arch
    design

Primary outcome measures

  • Evaluation of the depth of the shape of the intaglio surface of full-arch and its association with increased marginal bone level. [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
Secondary outcome measures (6)
  • Probing Depth of the implants [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
  • Bleeding on Probing of the implants [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
  • Modified Plaque Index [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
  • Marginal Recession [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
  • Suppuration [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]
  • Keratinized mucosa width [Time frame: The measurements will be assessed during the unique visit of the patient in the study.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Pittsburgh, School of Dental Medicine — Pittsburgh

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. PMID 3507627
  • Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424. PMID 29926949

Identifiers

NCT: NCT06636097 · STUDY23100028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗