ClinicalTrials.gg
CompletedNCT07873775Updated Oct 14, 2026

Accuracy of Intraoral Scanners in Patients With Maxillary Defects

An interventional study of Medit i700 and TRIOS 3 in Acquired Maxillary Defect, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Ain Shams University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Oct 2024, registered Oct 2026).
Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 59 Years
Sex
All
01

Study summary

This clinical study evaluated the trueness of two intraoral scanners in patients with acquired maxillary defects. Eight patients with unilateral maxillary defects were included. Each patient underwent direct intraoral scanning using the Medit i700 and TRIOS 3 intraoral scanners. A conventional impression was also obtained, and the resulting stone cast was digitized using a desktop scanner to serve as the reference dataset. The intraoral scan datasets were compared with the reference scan using three-dimensional analysis to assess trueness. patient-reported obturator function was also evaluated using the Obturator Functioning Scale (OFS)The study aimed to determine whether the two intraoral scanners differed in their ability to accurately record maxillary defect anatomy under clinical conditions.the study also evaluated patient-reported obturator function using the Obturator Functioning Scale (OFS)

Read the detailed description

Patients with acquired unilateral maxillary defects who fulfilled the eligibility criteria were recruited for this study. For each participant, a conventional impression of the maxillary arch and defect was obtained and poured to produce a stone master cast. The master cast was digitized using a desktop scanner, and the resulting digital model was used as the reference dataset.

Each participant was subsequently scanned intraorally using two intraoral scanning systems: Medit i700 and TRIOS 3. The scanning procedures were performed according to a standardized scanning sequence to record the remaining dentition, palatal tissues, and maxillary defect. The digital datasets obtained from both intraoral scanners were exported and compared with the reference dataset using three-dimensional surface analysis.in addition, patient-reported obturator function was assessed using the Obturator Functioning Scale (OFS) following obturator rehabilitation Trueness was assessed by measuring the three-dimensional deviation between each intraoral scan and the corresponding reference scan. Lower deviation values indicated closer agreement with the reference dataset.

The primary objective was to compare the trueness of the two intraoral scanners when recording acquired maxillary defects. Patient-reported obturator function constituted the secondary clinical outcome.

02

Conditions studied

  • Acquired Maxillary Defect

Keywords

  • Maxillary defect
  • Intraoral scanner
  • Digital impression
  • Trueness
  • Medit i700 , TRIOS 3
  • Obturator
  • Maxillectomy
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patients aged 18 to 59 years.
  • Acquired maxillary defects classified as Aramany Class II.
  • Completely healed maxillary defects, 6 to 12 months after surgical resection.
  • Sound abutment teeth free from active caries and significant periodontal disease.
  • Adequate mouth opening.
  • Adequate salivary flow.
  • Good oral hygiene.
  • Ability and willingness to comply with the study procedures.

Exclusion criteria

Exclusion Criteria:

  • Patients aged 60 years or older.
  • History of chemotherapy or radiotherapy affecting the maxillofacial region.
  • Congenital cleft-related maxillary defects.
  • Limited mouth opening or trismus.
  • Severe gag reflex.
  • Xerostomia.
  • Unhealed surgical defects.
  • Neuromuscular disorders that may interfere with the study procedures.
  • Inability or unwillingness to comply with the study procedures.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Intraoral Scanning Group

    all participants underwent intraoral scanning using both the Medit i700 and TRIOS 3 intraoral scanners. The resulting datasets were compared with a desktop-scanned reference dataset obtained from a conventional impression and stone cast.

    Device: Medit i700 · Device: TRIOS 3

Interventions

  • DeviceMedit i700

    All participants underwent intraoral scanning using both the Medit i700 and TRIOS 3 intraoral scanners. The resulting datasets were compared with a desktop-scanned reference dataset obtained from a conventional impression and stone cast.

  • DeviceTRIOS 3

    All participants underwent intraoral scanning using both the Medit i700 and TRIOS 3 intraoral scanners. The resulting datasets were compared with a desktop-scanned reference dataset obtained from a conventional impression and stone cast.

06

What researchers measure

Primary outcomes

  1. Three-Dimensional accuracy (Trueness) of Intraoral Scans

    Trueness will be assessed by calculating the root mean square (RMS) three-dimensional surface deviation between each intraoral scan obtained with the Medit i700 and TRIOS 3 and the corresponding desktop-scanned reference dataset. Lower RMS values indicate closer agreement with the reference dataset.

    Time frame: Immediately after completion of the scanning procedures for each participant.

Secondary outcomes

  1. Patient-Reported Obturator Function

    Patient-reported obturator function was assessed using the Obturator Functioning Scale (OFS).

    Time frame: One month after obturator delivery

07

Study locations

1 site
  • Faculty of Dentistry, Ain Shams University
    Cairo, Cairo Governorate +20, Egypt
08

References and documents

Individual participant data

Plan to share: No — "Individual participant data will not be publicly shared because of patient confidentiality and ethical considerations."

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2024 to primary completion in Aug 2026, 21 months.

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

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartActual
Oct 10, 2024
Primary completionActual
Aug 1, 2026
CompletionActual
Sep 1, 2026
Last update
Oct 14, 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.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873775
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Oct 10, 2024
Primary completion
Aug 1, 2026
Completion
Sep 1, 2026
Last update
Oct 14, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion