EdentulismNCT07037407
Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges
A study testing IOS and WTI in people with Edentulism and Edentulous Alveolar Ridge, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial summary
In vivo prospective clinical study will be designed, 12 participants will be included. After intraoral scanning, a conventional impression is made for each patient. The groups will be compared for accuracy. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Edentulism, Edentulous Alveolar Ridge, Edentulous Alveolar Ridge With Labial Resorption
- What is being tested?
- IOS and WTI
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Oct 2024to 24 Apr 2025
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Inclusion criteria for participant selection will be as follows: 1. completely edentulous patients with maxillary flabby ridge; 2. Absence of infectious diseases; 3. Systemic good health (ASA-1/ASA-2). .; 4. Age between 50 and 75 years; 5. Willingness to cooperate throughout the data collection process.
Exclusion Criteria:Exclusion criteria included: 1. Presence of any remaining teeth; 2. Inability to comprehend the study's objectives and procedures; 3. ridge defect or lesion; 4. Postoperative scarring on the ridge; 5. Limitations in mouth opening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Assessment of Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges: A Prospective Clinical Study
In vivo prospective clinical study will be designed, 12 participants will be included. After intraoral scanning, a conventional impression is made for each patient. The groups will be compared for accuracy.
Read the detailed description
- Recruit 12 eligible edentulous patients
- Scanning Process: Perform five intraoral scans (IOS) of the maxillary flabby ridges for each patient. . WTI: perform five WTI for each patient
- STL Export: Export scans and corresponding cast scans obtained via the Window Technique Impression (WTI) as STL files using the intraoral scanner software.
- 3D Distance Measurement: Import IOS and cast STL files into Geomagic Wrap 2017 for a two-phase best-fit alignment, using the Cast scan as the reference for evaluating trueness and precision.
- Comparison of Scans:
- Compare the IOS scan and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness -compare WTI and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness-
- Compare each of the five IOS impressions by using each scan as a reference against the others to calculate precision.
- Compare each of the five WTI impressions by using each scan as a reference against the others to calculate precision. • Deviation Analysis: Generate a color difference map of each superimposition for visual analysis of deviation patterns.
- Conditions
- Edentulism, Edentulous Alveolar Ridge, Edentulous Alveolar Ridge With Labial Resorption, Flabby Ridge
- Being tested
- IOS, WTI
- Keywords
- Flabby ridge, IOS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOSProcedure or surgery
Intra oral scanning
WTIProcedure or surgery
window technique Impression
| Study group | Role | What they receive |
|---|---|---|
| WTI | Active comparator | Control: Window technique for Maxillary flabby ridge using two consistencies of PVS impression material then poured to obtain a stone model which will be scanned using a laboratory extra oral scan to convert it into an STL file (WTI) Receives: Procedure: WTI |
| IOS | Experimental | intra oral scanning of flabby ridge Receives: Procedure: IOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy evaluation
Accuracy Evaluation: The accuracy of the digital impressions versus conventional impression based on trueness and precision will be evaluated.
- Trueness: Trueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files.
Precision: Precision is a statistical measure that quantifies the level of similarity between repeated samples within the same group. In the context of this study, the IOS impression STL files will be compared to each other in a manner similar to the previous comparisons
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start18 Oct 2024
- Primary completion24 Mar 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina ElAwady, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037407
- Sponsor's protocol ID
- MSA University REC-D4210-4
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Assessment of Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07037407
- Acronym / sponsor ID
- MSA University REC-D4210-4
- Conditions
- Edentulism, Edentulous Alveolar Ridge, Edentulous Alveolar Ridge With Labial Resorption, Flabby Ridge
- Keywords
- Flabby ridge, IOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 25 Jun 2025 (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.
In vivo prospective clinical study will be designed, 12 participants will be included. After intraoral scanning, a conventional impression is made for each patient. The groups will be compared for accuracy.
Detailed description
- Recruit 12 eligible edentulous patients
- Scanning Process: Perform five intraoral scans (IOS) of the maxillary flabby ridges for each patient. . WTI: perform five WTI for each patient
- STL Export: Export scans and corresponding cast scans obtained via the Window Technique Impression (WTI) as STL files using the intraoral scanner software.
- 3D Distance Measurement: Import IOS and cast STL files into Geomagic Wrap 2017 for a two-phase best-fit alignment, using the Cast scan as the reference for evaluating trueness and precision.
- Comparison of Scans:
- Compare the IOS scan and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness -compare WTI and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness-
- Compare each of the five IOS impressions by using each scan as a reference against the others to calculate precision.
- Compare each of the five WTI impressions by using each scan as a reference against the others to calculate precision. • Deviation Analysis: Generate a color difference map of each superimposition for visual analysis of deviation patterns.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WTI | Active comparator | Procedure: WTIControl: Window technique for Maxillary flabby ridge using two consistencies of PVS impression material then poured to obtain a stone model which will be scanned using a laboratory extra oral scan to convert it into an STL file (WTI) |
| IOS | Experimental | Procedure: IOSintra oral scanning of flabby ridge |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IOSIntra oral scanning | Procedure or surgery | IOS |
| WTIwindow technique Impression | Procedure or surgery | WTI |
Primary outcome
accuracy evaluation
Time frame: 1 month
Accuracy Evaluation: The accuracy of the digital impressions versus conventional impression based on trueness and precision will be evaluated. - Trueness: Trueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files. Precision: Precision is a statistical measure that quantifies the level of similarity between repeated samples within the same group. In the context of this study, the IOS impression STL files will be compared to each other in a manner similar to the previous comparisons
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 25 Jun 2025.
- Individual participant dataSharing planned: No
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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. 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 IOS and WTI in people with Edentulism and Edentulous Alveolar Ridge, run by October University for Modern Sciences and Arts 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?
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 25 Jun 2025. 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?
accuracy evaluation (time frame: 1 month). 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 25 Jun 2025.