Complete EdentulismNCT07290322
Denture Retention of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients
A study testing Intaorally scanned methods and extraorally scanned methods 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 denture retention in intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main question is : 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Intaorally scanned methods and extraorally scanned methods
- 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 2024to 1 Sep 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
- completely edentulous patients
- Angle's class I Skeletal relationship
- normal facial symmetry
- comparative patients
Who cannot join
- tempromandibular disorders
- uncontrolled diabetes
- patients with neuromuscular disorders
- severe psychiatric disorders
- angle's class II and III skeletal relationship
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate denture retention in intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main question is : 1. Do intra-orally scanned dentures provide better retention compared to extra-orally scanned dentures? Researchers will compare the intra-orally scanned denture group to the extraorally scanned denture group to determine if one method leads to superior retention records.
Participants will:
- Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention. 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 denture retention 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 retention 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 objective of this study are:
- To determine if intra-orally scanned dentures provide higher denture retention compared to extra-orally scanned dentures.
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 be exposed to The assessment of denture retention which involves measuring the force required to dislodge the denture in different directions .
- Conditions
- Complete Edentulism
- Being tested
- Intaorally scanned methods, extraorally scanned methods
- Keywords
- Intraoral scanning, Extra oral scaning, Complete edentulism, Digital, denture retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intaorally scanned methodsDevice
the intraoral scanning method involves capturing digital impressions of the oral cavity directly using the 3 shape scanner . this method eliminates the need for traditional impression material providing a more comfortable and precise imaging process , the digital impressions are the utilized to design and fabricate maxillary dentures using 3D printing technology . the intervention focuses on evaluating denture's retention
extraorally scanned methodsDevice
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 denture retention
| Study group | Role | What they receive |
|---|---|---|
| Intra-Orally Scanned Dentures | Experimental | Participants in this arm will recieve maxillary dentures fabricated using intraoral scanning technology . digital impressions of the oral cavity will be captured directly using the 3 shape 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 retention . Receives: Device: extraorally scanned methods |
| Extra-Orally Scanned Dentures | Active comparator | Participants in this arm will recieve maxillary dentures fabricated using extraoral scanning technology . conventional impressions of the oral cavity will first be taken using traditional impression material , these impressions will then be scanned externally using the 3Shape scanner to create digital models . these digital models will be used to design and 3D print the dentures , which will then be fitted and evaluated for retention . Receives: Device: Intaorally scanned methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Denture Retention
Measured: the patient is observed for three weeks as awash_out period after each type of scan so that i can compare the denture retention across those periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start3 Dec 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Rehab Rabie Abdalla, Cairo University
- Investigators
- Rehab R Abdalla, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290322
- Sponsor's protocol ID
- 21-12-2023
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, no final decision has been made regarding the sharing of IPD. We will consider sharing the data based on ethical guidelines and the research objectives in the future.
Publications
1-Comparative Accuracy of Intraoral and Extraoral Digital Scanners by MA Mansoor et al., published in the Journal of Prosthetic Dentistry in 2024. 2.The Accuracy of Intraoral Scan in Obtaining Digital Impressions of Edentulous Jaws by Y Wang et al., published in the Journal of Prosthetic Dentistry in 2024. 3.Comparison of Intraoral and Extraoral Digital Scanners: Evaluation of Surface Topography and Precision, published on ResearchGate in 2020. 4.Effect of Different Scanning Protocols on the Retention of Complete Dentures by SM Fadl et al., published in the Egyptian Dental Journal in 2023.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denture Retention of Intra-orally Scanned Versus Extra-orally Scanned Digitally Printed Maxillary Denture in Completely Edentulous Patients
- ClinicalTrials.gov ID
- NCT07290322
- Acronym / sponsor ID
- 21-12-2023
- Conditions
- Complete Edentulism
- Keywords
- Intraoral scanning, Extra oral scaning, Complete edentulism, Digital, denture retention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 18 Dec 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 denture retention in intra-orally scanned versus extra-orally scanned digitally printed maxillary dentures in completely edentulous patients. The main question is : 1. Do intra-orally scanned dentures provide better retention compared to extra-orally scanned dentures? Researchers will compare the intra-orally scanned denture group to the extraorally scanned denture group to determine if one method leads to superior retention records.
Participants will:
- Receive both types of dentures (intra-orally scanned and extra-orally scanned), with a three-week wash-out period between each intervention. 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 denture retention 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 retention 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 objective of this study are:
- To determine if intra-orally scanned dentures provide higher denture retention compared to extra-orally scanned dentures.
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 be exposed to The assessment of denture retention which involves measuring the force required to dislodge the denture in different directions .
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: extraorally scanned methodsParticipants in this arm will recieve maxillary dentures fabricated using intraoral scanning technology . digital impressions of the oral cavity will be captured directly using the 3 shape 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 retention . |
| Extra-Orally Scanned Dentures | Active comparator | Device: Intaorally scanned methodsParticipants in this arm will recieve maxillary dentures fabricated using extraoral scanning technology . conventional impressions of the oral cavity will first be taken using traditional impression material , these impressions will then be scanned externally using the 3Shape scanner to create digital models . these digital models will be used to design and 3D print the dentures , which will then be fitted and evaluated for retention . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- completely edentulous patients
- Angle's class I Skeletal relationship
- normal facial symmetry
- comparative patients
Key exclusion criteria (5 listed)
- tempromandibular disorders
- uncontrolled diabetes
- patients 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 |
|---|---|---|
| Intaorally scanned methodsthe intraoral scanning method involves capturing digital impressions of the oral cavity directly using the 3 shape scanner . this method eliminates the need for traditional impression material providing a more comfortable and precise imaging process , the digital impressions are the utilized to design and fabricate maxillary dentures using 3D printing technology . the intervention focuses on evaluating denture's retention | Device | Extra-Orally Scanned Dentures |
| extraorally scanned methodsThe 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 denture retention | Device | Intra-Orally Scanned Dentures |
Primary outcome
Denture Retention
Time frame: the patient is observed for three weeks as awash_out period after each type of scan so that i can compare the denture retention across those periods
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 18 Dec 2025.
- Results publication1-Comparative Accuracy of Intraoral and Extraoral Digital Scanners by MA Mansoor et al., published in the Journal of Prosthetic Dentistry in 2024. 2.The Accuracy of Intraoral Scan in Obtaining Digital Impressions of Edentulous Jaws by Y Wang et al., published in the Journal of Prosthetic Dentistry in 2024. 3.Comparison of Intraoral and Extraoral Digital Scanners: Evaluation of Surface Topography and Precision, published on ResearchGate in 2020. 4.Effect of Different Scanning Protocols on the Retention of Complete Dentures by SM Fadl et al., published in the Egyptian Dental Journal in 2023.
- This study, titled "Effect of Different Scanning Protocols on the Retention of Duplicated Maxillary Complete Dentures," investigates how various scanning techniques influence the retention and fit of maxillary complete dentures. It provides insights intoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, no final decision has been made regarding the sharing of IPD. We will consider sharing the data based on ethical guidelines and the research objectives in the future.
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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.
Rehab R Abdalla principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intaorally scanned methods and extraorally scanned methods 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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?
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?
Denture Retention (time frame: the patient is observed for three weeks as awash_out period after each type of scan so that i can compare the denture retention across those periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07290322, which also lists 1 linked publication.
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 18 Dec 2025.