Acquired Maxillary DefectNCT07873775
Accuracy of Intraoral Scanners in Patients With Maxillary Defects
A study testing Medit i700 and TRIOS 3 in people with Acquired Maxillary Defect, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Acquired Maxillary Defect
- What is being tested?
- Medit i700 and TRIOS 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Unhealed surgical defects.
- Neuromuscular disorders that may interfere with the study procedures.
- Inability or unwillingness to comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate, +20
About this study
Official title: Quality of Life and Accuracy of Different Intraoral Scanners in Acquired Palatal Defect
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.
- Conditions
- Acquired Maxillary Defect
- Being tested
- Medit i700, TRIOS 3
- Keywords
- Maxillary defect, Intraoral scanner, Digital impression, Trueness, Medit i700 , TRIOS 3, Obturator, Maxillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medit i700Device
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.
TRIOS 3Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraoral Scanning Group | Experimental | 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. Receives: Device: Medit i700; Device: TRIOS 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: One month after obturator delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start10 Oct 2024
- Primary completion1 Aug 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Maxillary DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant underwent intraoral scanning using both Medit i700 and TRIOS 3, and the resulting datasets were compared with a desktop-scanned reference dataset.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873775
- Sponsor's protocol ID
- FDASU-REC ID042305
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be publicly shared because of patient confidentiality and ethical considerations."
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Accuracy of Different Intraoral Scanners in Acquired Palatal Defect
- ClinicalTrials.gov ID
- NCT07873775
- Acronym / sponsor ID
- FDASU-REC ID042305
- Conditions
- Acquired Maxillary Defect
- Keywords
- Maxillary defect, Intraoral scanner, Digital impression, Trueness, Medit i700 , TRIOS 3, Obturator, Maxillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant underwent intraoral scanning using both Medit i700 and TRIOS 3, and the resulting datasets were compared with a desktop-scanned reference dataset.
| Arm | Type | Receives |
|---|---|---|
| Intraoral Scanning Group | Experimental | Device: Medit i700, Device: TRIOS 3all 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medit i700All 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 | Intraoral Scanning Group |
| TRIOS 3All 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 | Intraoral Scanning Group |
Primary outcome
Three-Dimensional accuracy (Trueness) of Intraoral Scans
Time frame: Immediately after completion of the scanning procedures for each participant.
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.
1 secondary outcome
Patient-Reported Obturator Function
Time frame: One month after obturator delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. "Individual participant data will not be publicly shared because of patient confidentiality and ethical considerations."
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medit i700 and TRIOS 3 in people with Acquired Maxillary Defect, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-Dimensional accuracy (Trueness) of Intraoral Scans (time frame: Immediately after completion of the scanning procedures for each participant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.