Complete EdentulismNCT06846619
"Patient Satisfaction with Intra-Oral Vs. Extra-Oral Scanned 3D-Printed Dentures: an in Vivo Study"
A study testing Intra-Oral Scanning Method and Extra orally scanned in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate patient satisfaction with intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Intra-Oral Scanning Method and Extra orally scanned
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Dec 2023to 1 Sep 2025
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous patients
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
Who cannot join
- -Temporomandibular disorders
- Uncontrolled diabetes
- Patient's with neuromuscular disorders
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry-Cairo university
Cairo, 22022
Lujayn A Mahmoud, BDS, 01000642385, Lujaynamr@dentistry.cu.edu.eg
About this study
Official title: Patient Satisfaction of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients, in Vivo Study.
The goal of this clinical trial is to evaluate patient satisfaction with intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main questions it aims to answer are:
- Do intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures?
- Are there significant differences in comfort, fit, aesthetics and phonetics between the two types of dentures?
Read more
Researchers will compare the intra-orally scanned denture group to the extra-orally scanned denture group to determine if one method leads to superior patient-reported outcomes.
Participants will:
- Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention.
- Complete satisfaction surveys to assess comfort, fit, and aesthetics after using each type of denture.
The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.
Read the detailed description
The goal of this clinical trial is to evaluate and compare patient satisfaction with intra-orally scanned and extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. This in vivo study seeks to provide insights into how the scanning method impacts the comfort, fit, and aesthetics of maxillary dentures, ultimately guiding clinicians in choosing the most patient-preferred approach.
Study Design and Objectives
This study involves eight completely edentulous participants who will receive both types of dentures-one set based on intra-oral scanning and another based on extra-oral scanning. A wash-out period of two weeks between the use of each denture ensures that the effects of one intervention do not influence the results of the other. The primary objectives of this study are:
- To determine if intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures.
- To assess specific satisfaction factors, including comfort, fit, and aesthetic appearance, for both denture types.
Study Methodology
Participants will undergo the following steps:
- Scans and Fabrication:
- Intra-oral scanning will be performed using the 3Shape scanner to capture precise digital impressions of the oral cavity.
- For the extra-oral scanning, conventional impressions will first be taken, and these will be scanned externally using the same scanner to create digital models.
- Both types of digital models will be used to fabricate maxillary dentures using 3D printing technology.
- Fitting and Wash-out Period:
- Participants will first use one type of denture (either intra-oral or extra-oral scanned) for a designated period.
- After a two-week wash-out period without wearing dentures, they will switch to the other type of denture.
- Data Collection:
- After wearing each type of denture, participants will complete structured satisfaction questionnaire focusing on key parameters: comfort during daily use, overall fit, and aesthetic appeal.
Data Analysis
The study will compare satisfaction scores and qualitative responses between the two scanning methods. Statistical analyses will be conducted to identify significant differences in patient-reported outcomes.
Expected Impact
This study aims to provide clinicians with evidence-based guidance on whether intra-oral or extra-oral scanning results in better patient satisfaction for digitally printed maxillary dentures. By focusing on the user experience, this research contributes to improving prosthodontic care for completely edentulous patients.
- Conditions
- Complete Edentulism
- Being tested
- Intra-Oral Scanning Method, Extra orally scanned
- Keywords
- Intraoral scanning, Extra oral scaning, Complete edentulism, Digital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-Oral Scanning MethodDevice
Intervention Description:
The intra-oral scanning method involves capturing digital impressions of the oral cavity directly using the 3Shape scanner. This method eliminates the need for traditional impression materials, providing a more comfortable and precise imaging process. The digital impressions are then utilized to design and fabricate maxillary dentures using 3D printing technology. The intervention focuses on evaluating patient satisfaction with the dentures in terms of comfort, fit, and aesthetics.
Extra orally scannedDevice
The extra-oral scanning method involves creating conventional impressions of the oral cavity using traditional impression materials. These impressions are then scanned externally using the 3Shape scanner to produce digital models. The digital models are used to design and fabricate maxillary dentures through 3D printing technology. This intervention aims to assess patient satisfaction with the dentures based on comfort, fit, and aesthetics.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Orally Scanned Dentures | Experimental | Arm Description:
Participants in this arm will receive maxillary dentures fabricated using intra-oral scanning technology. Digital impressions of the oral cavity will be captured directly using the 3Shape TRIOS intraoral scanner, eliminating the need for conventional impression materials. These digital impressions will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. Receives: Device: Intra-Oral Scanning Method; Device: Extra orally scanned |
| Extra-Orally Scanned Dentures | Active comparator | Arm Description:
Participants in this arm will receive maxillary dentures fabricated using extra-oral scanning technology. Conventional impressions of the oral cavity will first be taken using traditional impression materials. These impressions will then be scanned externally using the 3Shape scanner to create digital models. The digital models will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. Receives: Device: Intra-Oral Scanning Method; Device: Extra orally scanned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Patient satisfaction will be assessed using a Visual Analogue Scale questionnaire covering cleanliness, comfort, esthetics,phonetics and fit
Measured: Assessment will be conducted after patient delivery at 6 months after wearing each denture where as a washout period of two weeks will be observed between the two interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start3 Dec 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lujayn Amr Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846619
- Sponsor's protocol ID
- 12-2024
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients, in Vivo Study.
- ClinicalTrials.gov ID
- NCT06846619
- Acronym / sponsor ID
- 12-2024
- Conditions
- Complete Edentulism
- Keywords
- Intraoral scanning, Extra oral scaning, Complete edentulism, Digital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 26 Feb 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.
The goal of this clinical trial is to evaluate patient satisfaction with intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main questions it aims to answer are:
- Do intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures?
- Are there significant differences in comfort, fit, aesthetics and phonetics between the two types of dentures?
Researchers will compare the intra-orally scanned denture group to the extra-orally scanned denture group to determine if one method leads to superior patient-reported outcomes.
Participants will:
- Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention.
- Complete satisfaction surveys to assess comfort, fit, and aesthetics after using each type of denture.
The study aims to provide evidence on the optimal scanning method for digitally printed maxillary dentures in edentulous patients.
Detailed description
The goal of this clinical trial is to evaluate and compare patient satisfaction with intra-orally scanned and extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. This in vivo study seeks to provide insights into how the scanning method impacts the comfort, fit, and aesthetics of maxillary dentures, ultimately guiding clinicians in choosing the most patient-preferred approach.
Study Design and Objectives
This study involves eight completely edentulous participants who will receive both types of dentures-one set based on intra-oral scanning and another based on extra-oral scanning. A wash-out period of two weeks between the use of each denture ensures that the effects of one intervention do not influence the results of the other. The primary objectives of this study are:
- To determine if intra-orally scanned dentures provide higher patient satisfaction compared to extra-orally scanned dentures.
- To assess specific satisfaction factors, including comfort, fit, and aesthetic appearance, for both denture types.
Study Methodology
Participants will undergo the following steps:
- Scans and Fabrication:
- Intra-oral scanning will be performed using the 3Shape scanner to capture precise digital impressions of the oral cavity.
- For the extra-oral scanning, conventional impressions will first be taken, and these will be scanned externally using the same scanner to create digital models.
- Both types of digital models will be used to fabricate maxillary dentures using 3D printing technology.
- Fitting and Wash-out Period:
- Participants will first use one type of denture (either intra-oral or extra-oral scanned) for a designated period.
- After a two-week wash-out period without wearing dentures, they will switch to the other type of denture.
- Data Collection:
- After wearing each type of denture, participants will complete structured satisfaction questionnaire focusing on key parameters: comfort during daily use, overall fit, and aesthetic appeal.
Data Analysis
The study will compare satisfaction scores and qualitative responses between the two scanning methods. Statistical analyses will be conducted to identify significant differences in patient-reported outcomes.
Expected Impact
This study aims to provide clinicians with evidence-based guidance on whether intra-oral or extra-oral scanning results in better patient satisfaction for digitally printed maxillary dentures. By focusing on the user experience, this research contributes to improving prosthodontic care for completely edentulous patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Orally Scanned Dentures | Experimental | Device: Intra-Oral Scanning Method, Device: Extra orally scannedArm Description: Participants in this arm will receive maxillary dentures fabricated using intra-oral scanning technology. Digital impressions of the oral cavity will be captured directly using the 3Shape TRIOS intraoral scanner, eliminating the need for conventional impression materials. These digital impressions will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. |
| Extra-Orally Scanned Dentures | Active comparator | Device: Intra-Oral Scanning Method, Device: Extra orally scannedArm Description: Participants in this arm will receive maxillary dentures fabricated using extra-oral scanning technology. Conventional impressions of the oral cavity will first be taken using traditional impression materials. These impressions will then be scanned externally using the 3Shape scanner to create digital models. The digital models will be used to design and 3D-print the dentures, which will then be fitted and evaluated for comfort, fit, and aesthetics. Participants will wear these dentures for a specified period and provide feedback through structured satisfaction surveys. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Completely edentulous patients
- Angle's Class I skeletal relationship
- Normal facial symmetry
- Cooperative patients
Key exclusion criteria (5 listed)
- -Temporomandibular disorders
- Uncontrolled diabetes
- Patient's with neuromuscular disorders
- Severe psychiatric disorders
- Angle's class II and III skeletal relationship.
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 |
|---|---|---|
| Intra-Oral Scanning MethodIntervention Description: The intra-oral scanning method involves capturing digital impressions of the oral cavity directly using the 3Shape scanner. This method eliminates the need for traditional impression materials, providing a more comfortable and precise imaging process. The digital impressions are then utilized to design and fabricate maxillary dentures using 3D printing technology. The intervention focuses on evaluating patient satisfaction with the dentures in terms of comfort, fit, and aesthetics. | Device | Extra-Orally Scanned Dentures, Intra-Orally Scanned Dentures |
| Extra orally scannedThe extra-oral scanning method involves creating conventional impressions of the oral cavity using traditional impression materials. These impressions are then scanned externally using the 3Shape scanner to produce digital models. The digital models are used to design and fabricate maxillary dentures through 3D printing technology. This intervention aims to assess patient satisfaction with the dentures based on comfort, fit, and aesthetics. | Device | Extra-Orally Scanned Dentures, Intra-Orally Scanned Dentures |
Primary outcome
Patient satisfaction
Time frame: Assessment will be conducted after patient delivery at 6 months after wearing each denture where as a washout period of two weeks will be observed between the two interventions.
Patient satisfaction will be assessed using a Visual Analogue Scale questionnaire covering cleanliness, comfort, esthetics,phonetics and fit
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 26 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Oral Scanning Method and Extra orally scanned in people with Complete Edentulism, run by Cairo 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Feb 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?
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 Lujayn A Mahmoud, BDS (01000642385, Lujaynamr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: Assessment will be conducted after patient delivery at 6 months after wearing each denture where as a washout period of two weeks will be observed between the two interventions.). 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 26 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.