ClinicalTrials.gg
RecruitingNCT07505485AIpreopUpdated Apr 15, 2026

Artificial Intelligence-Based Assessment of Endosseous Lesions

An interventional study of AI assisted Evaluation in Maxillary Cyst and Mandibular Cyst, sponsored by University of Bari Aldo Moro. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-15.

Sponsored by University of Bari Aldo Moro · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Despite these advances, CBCT interpretation remains largely qualitative and dependent on the clinician's experience. Conventional evaluation is based on two-dimensional slices and linear measurements, which may underestimate lesion complexity and spatial distribution.

Recent developments in Artificial Intelligence in Medicine have introduced automated image segmentation tools capable of identifying lesion boundaries and calculating volumetric data. These technologies allow a transition from subjective assessment to objective, reproducible quantification.

The potential clinical advantages include:

  • Objective measurement of lesion size (volume in mm³)
  • Improved surgical planning
  • Enhanced prediction of anatomical involvement
  • Reduction of diagnostic errors
  • Standardization of follow-up and outcome assessment Therefore, the aim of the present study was to evaluate the clinical impact of AI-based segmentation and volumetric analysis of endosseous lesions compared to conventional CBCT interpretation.
02

Conditions studied

  • Maxillary Cyst
  • Mandibular Cyst

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03

In context

Cysts

67 studies on the registry are indexed under Cysts; 16 are open to participants now.

This study's planned enrollment of 10 is below the median of 48 across 40 interventional studies indexed under Cysts.

Browse Cysts studies →

Lead sponsor

University of Bari Aldo Moro is the lead sponsor of 30 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Good health according to the System of the American Society of Anesthesiology
  • Aged older than 18 years
  • No general medical for surgery

Exclusion criteria

Exclusion Criteria:

  • Smoking more than 15 cigarettes a day

    • Pregnancy
    • Acute infections
Terms in these criteria, in plain language(1)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • No intervention
    Patients with endosseous lesion-Analyzed using conventional CBCT
  • Experimental
    Patients with endosseous lesion- AI-assisted evaluation

    * Automated segmentation of the lesion * 3D reconstruction * Volumetric calculation

    Diagnostic Test: AI assisted Evaluation

Interventions

  • Diagnostic testAI assisted Evaluation

    CBCT scans were processed using AI-based software capable of: * Automated segmentation of the lesion * 3D reconstruction * Volumetric calculation

06

What researchers measure

Primary outcomes

  1. Time required for CBCT interpretation (minutes)

    assessment of the time required for CBCT interpretation by the surgeon. A digital stopwatch was used to record the operative time required for each procedural step, with measurements expressed in seconds, in order to obtain an objective and standardized assessment of execution time.

    Time frame: Day 1

Secondary outcomes

  1. Intraoperative and Postoperative Complications

    * Unexpected endodontic treatment of adjacent teeth * Intraoperative nerve exposure * Paresthesia * Excessive bone removal * Incomplete lesion removal * Postoperative infection * Delayed healing * Sinus involvement * Root damage to adjacent teeth

    Time frame: Day 1

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2026; primary completion for May 2026, 1 month later.

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

Registered
Mar 21, 2026
First posted
Apr 1, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
May 1, 2026
CompletionEst.
May 1, 2026
Last update
Apr 15, 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 Apr 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07505485
Lead sponsor
University of Bari Aldo Moro
Responsible party
Giuseppe D'Albis (Principal Investigator, University of Bari Aldo Moro) — Principal investigator
First posted
Apr 1, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

Giuseppe D'Albis, Dr.
Contact
giuseppe.dalbis@uniba.it
+393495103642
Saverio Capodiferro, Prof.
Contact
saverio.capodiferro@uniba.it
Giuseppe D'Albis, Dr
principal investigator · University of Bari Aldo Moro
Saverio Capodiferro, Prof
study director · University of Bari Aldo Moro

Oversight

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

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