Peri-ImplantitisNCT06636097
Intaglio Surface of Full-arch Implant Supported Prosthesis
An observational study of Peri-Implantitis, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Full arch
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥ 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pittsburgh, School of Dental Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Effect of the Intaglio Surface of Full-arch Implant-supported on Marginal Bone Level: A Cross-sectional Study
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.
- Conditions
- Peri-Implantitis
- Being tested
- Full arch
- Keywords
- Peri-implantitis, Marginal Bone Level, Dental Implants, Full-arch Prosthesis, Hybrid prosthesis
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full archDevice
design
| Study group | Role | What they receive |
|---|---|---|
| Patients Rehabilitated with full-arch implant-supported prosthesis | All patients that are rehabilitated with full-arch implant-supported prosthesis Receives: Device: Full arch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
Secondary outcomes (6)
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.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
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.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
Modified Plaque Index
Plaque accumulation will be evaluated using the modified plaque index adapted for dental implants.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
Marginal Recession
The distance, in mm, between the implant platform and the mucosal margin.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
Suppuration
Assessed by the presence/absence of suppuration after gentle probing of the implants.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
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.
Measured: The measurements will be assessed during the unique visit of the patient in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start11 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Ravida, University of Pittsburgh
- Investigators
- Andrea Ravida, DDS, MS, PhD, Principal investigator, Program Director of the Periodontics and Implant Dentistry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636097
- Sponsor's protocol ID
- STUDY23100028
- Status last verified
- Sep 2026
- First submitted
- 8 Oct 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 3507627Araujo MG, Lindhe J. Peri-implant health. J Periodontol. 2018 Jun;89 Suppl 1:S249-S256. doi: 10.1002/JPER.16-0424.
PubMed 29926949