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Enrolling by Invitation

NCT Number: NCT06636097

Intaglio Surface of Full-arch Implant Supported Prosthesis

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh, School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Full arch

Device

design

Primary outcomes

  1. 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.

    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 outcomes

  1. Probing Depth of the implants

    Time frame: 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.

  2. Bleeding on Probing of the implants

    Time frame: 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.

  3. Modified Plaque Index

    Time frame: 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.

  4. Marginal Recession

    Time frame: 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.

  5. Suppuration

    Time frame: 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.

  6. Keratinized mucosa width

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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