Edentulous JawNCT07740798
Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions
A study testing Digital impression of the mandibular edentulous arch in people with Edentulous Jaw, run by Ain Shams University.
Trial summary
the relative accuracy of different intraoral scanner types specifically for capturing the complex morphology of edentulous arches, including peripheral borders and mobile tissues, remains an area of investigation, with conflicting reports in the literature. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Digital impression of the mandibular edentulous arch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- edentulous patients
- last teeth extraction 6 months before the impression procedures
Who cannot join
- un cooperative patients
- Neuromotor disorders
- Parkinsonism
- Tremors
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
the relative accuracy of different intraoral scanner types specifically for capturing the complex morphology of edentulous arches, including peripheral borders and mobile tissues, remains an area of investigation, with conflicting reports in the literature.
The purpose of this study is to compare the accuracy of different intraoral scanners with a laboratory scanner for digitizing impressions of edentulous mandible.
Read more
Completely edentulous patients will be gathered; final impressions will be taken for them using zinc oxide \& eugenol impression material then they will be scanned with intra oral and extra oral scanners for indirect digitalization.
Scans will be superimposed and compared using a software program for analysis for accuracy in the form of trueness
Read the detailed description
completely edentulous patients will be recruited.
Study procedures:
Custom trays will be fabricated and checked for extension, and then definitive impressions will be made with type-1 low fusing impression compound (Tracing sticks; Kemdent, UK) for border molding and zinc oxide eugenol impression paste (Cavex Holland B.N) for the impression. Reference markers will be placed on the impressions in anterior and posterior ridge areas.
The indirect digitalization of impressions will be made with two different Intraoral scanning devices and a laboratory scanner.
- Intra oral scanners are:
- Aoralscan (Shining 3D Tech. Co., Ltd. Hangzhou, China): structured light-optical triangulation technology.
- MEDIT i600 (Medit Corp. Seoul, South Korea): structured light-3d-in-motion video technology.
- Extra oral scanner: UP3D. Scans will be exported as standard tessellation language (STL) files. The STL files then will be compared using a 3D analysis software program for analysis.
For "trueness" measurements every STL file of each experimental group will be superimposed to the extra oral scan.
- Conditions
- Edentulous Jaw
- Being tested
- Digital impression of the mandibular edentulous arch
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital impression of the mandibular edentulous archOther
Digital impression of the mandibular edentulous arch will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness.
| Study group | Role | What they receive |
|---|---|---|
| Digital impression of the mandibular edentulous arch | Experimental | Digital impression of the mandibular edentulous arch will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness. Receives: Other: Digital impression of the mandibular edentulous arch |
What is being measured
The primary outcome is the main question the study is designed to answer.
trueness assessment of impression techniques for mandibular edentulous arches
Assessment of trueness of Digital impression of the mandibular edentulous arch using intra oral scanner will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness in relation to desktop scanner. Root mean square of trueness in m.m will be reported.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- final impressions will be taken for the participants using zinc oxide \& eugenol impression material then they will be scanned with intra oral and extra oral scanners for indirect digitalization. Scans will be superimposed and compared using a software program for analysis for accuracy in the form of trueness.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Abdelfatah, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740798
- Sponsor's protocol ID
- OOC-8-25-6
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions
- ClinicalTrials.gov ID
- NCT07740798
- Acronym / sponsor ID
- OOC-8-25-6
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 3 Aug 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.
the relative accuracy of different intraoral scanner types specifically for capturing the complex morphology of edentulous arches, including peripheral borders and mobile tissues, remains an area of investigation, with conflicting reports in the literature.
The purpose of this study is to compare the accuracy of different intraoral scanners with a laboratory scanner for digitizing impressions of edentulous mandible.
Completely edentulous patients will be gathered; final impressions will be taken for them using zinc oxide \& eugenol impression material then they will be scanned with intra oral and extra oral scanners for indirect digitalization.
Scans will be superimposed and compared using a software program for analysis for accuracy in the form of trueness
Detailed description
completely edentulous patients will be recruited.
Study procedures:
Custom trays will be fabricated and checked for extension, and then definitive impressions will be made with type-1 low fusing impression compound (Tracing sticks; Kemdent, UK) for border molding and zinc oxide eugenol impression paste (Cavex Holland B.N) for the impression. Reference markers will be placed on the impressions in anterior and posterior ridge areas.
The indirect digitalization of impressions will be made with two different Intraoral scanning devices and a laboratory scanner.
- Intra oral scanners are:
- Aoralscan (Shining 3D Tech. Co., Ltd. Hangzhou, China): structured light-optical triangulation technology.
- MEDIT i600 (Medit Corp. Seoul, South Korea): structured light-3d-in-motion video technology.
- Extra oral scanner: UP3D. Scans will be exported as standard tessellation language (STL) files. The STL files then will be compared using a 3D analysis software program for analysis.
For "trueness" measurements every STL file of each experimental group will be superimposed to the extra oral scan.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- final impressions will be taken for the participants using zinc oxide \& eugenol impression material then they will be scanned with intra oral and extra oral scanners for indirect digitalization. Scans will be superimposed and compared using a software program for analysis for accuracy in the form of trueness.
| Arm | Type | Receives |
|---|---|---|
| Digital impression of the mandibular edentulous arch | Experimental | Other: Digital impression of the mandibular edentulous archDigital impression of the mandibular edentulous arch will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- edentulous patients
- last teeth extraction 6 months before the impression procedures
Key exclusion criteria (4 listed)
- un cooperative patients
- Neuromotor disorders
- Parkinsonism
- Tremors
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 |
|---|---|---|
| Digital impression of the mandibular edentulous archDigital impression of the mandibular edentulous arch will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness. | Other | Digital impression of the mandibular edentulous arch |
Primary outcome
trueness assessment of impression techniques for mandibular edentulous arches
Time frame: 3 months
Assessment of trueness of Digital impression of the mandibular edentulous arch using intra oral scanner will be made by MEDIT i600 scanner (Medit Corp. Seoul, South Korea) followed by another digital impression of the same arch using Aoralscan scanner (Shining 3D Tech. Co., Ltd. Hangzhou, China). Both impressions will be compared to each other in terms of trueness in relation to desktop scanner. Root mean square of trueness in m.m will be reported.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Digital impression of the mandibular edentulous arch in people with Edentulous Jaw, run by Ain Shams University.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed, MD (01111191337, ahmedmostafa@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trueness assessment of impression techniques for mandibular edentulous arches (time frame: 3 months). 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 4 Aug 2026.