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Enrolling by invitationNCT06636097Updated Sep 10, 2026

Intaglio Surface of Full-arch Implant Supported Prosthesis

An observational study in Peri-Implantitis, sponsored by University of Pittsburgh. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Peri-Implantitis with a site in United States — 7 open to participants now, 9 under way, none of them phase 3. Peri-Implantitis · United States.

Planned enrollment
3rd of 10
50 · median 40
Started
2024
with 1 other
Observational
10 of 32
1 open now
Registered
30th of 32
by date
Lead sponsor
4 of 32
University of Pittsburgh

Among the 32 studies in Peri-Implantitis with a site in United States, this one is the 3rd largest by planned enrollment of the 10 observational ones, is one of 2 that started in 2024, is one of 10 observational ones, and was the 30th registered.

By phase

32 studies; the count open now beside each. This study's row is marked.

No phase15 · 6 open
Observationalthis study10 · 1 open
Phase 35 · 0 open
Phase 11 · 0 open
Phase 41 · 0 open

By the year they started

First in 2008; this study’s year is marked. 2 started in 2024.

Size and results

Median enrollment 42 across the 22 interventional studies, 40 across the 10 observational. Of the 21 that completed or were terminated, 7 (33%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 32 studies in Peri-Implantitis with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Peri-Implantitis

Browse trials for

Keywords

  • Peri-implantitis
  • Marginal Bone Level
  • Dental Implants
  • Full-arch Prosthesis
  • Hybrid prosthesis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( or ASA II).

Exclusion criteria

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 ;
  • Pregnant Patients.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients Rehabilitated with full-arch implant-supported prosthesis

    All patients that are rehabilitated with full-arch implant-supported prosthesis

    Device: Full arch

Interventions

  • DeviceFull arch

    design

06

What researchers measure

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.

    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.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

Secondary outcomes

  1. Probing Depth of the implants

    Using a periodontal probe we will register Probing Depth in 6 sites per implant. All measures will be in mm.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

  2. Bleeding on Probing of the implants

    Using a periodontal probe we will register Bleeding in 6 sites using the bleeding indexes modified for dental implants.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

  3. Modified Plaque Index

    Plaque accumulation will be evaluated using the modified plaque index adapted for dental implants.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

  4. Marginal Recession

    The distance, in mm, between the implant platform and the mucosal margin.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

  5. Suppuration

    Assessed by the presence/absence of suppuration after gentle probing of the implants.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

  6. Keratinized mucosa width

    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.

    Time frame: The measurements will be assessed during the unique visit of the patient in the study.

07

Study locations

1 site
08

References and documents

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. PubMed 3507627 ↗
  • Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424. PubMed 29926949 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2024
First posted
Oct 10, 2024
StartActual
Jun 11, 2024
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636097
Responsible party
Andrea Ravida (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Oct 10, 2024
Start date
Jun 11, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Andrea Ravida, DDS, MS, PhD
principal investigator · Program Director of the Periodontics and Implant Dentistry Department

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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