Complete EdentulismNCT07740278
3D Printing Orientation and Film Thickness for Maxillary Complete Dentures
A study testing 0° 3D-Printed Maxillary Complete Denture, 45° 3D-Printed Maxillary Complete Denture and 90° 3D-Printed Maxillary Complete Denture in people with Complete Edentulism and Maxillary Complete Denture Rehabilitation, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complete Edentulism, Maxillary Complete Denture Rehabilitation, Prosthodontics
- What is being tested?
- 0° 3D-Printed Maxillary Complete Denture, 45° 3D-Printed Maxillary Complete Denture and 90° 3D-Printed Maxillary Complete Denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2026to 1 Mar 2027
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients with good local and systemic health.
- Patients age ranging from 50 to 70 years old.
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
Who cannot join
- Patients with any oral diseases which may affect denture construction
- Patients with oral parafunctional habits.
- Patients with tempro-mandibular disorders
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, Tanta University
Tanta, Gharbia Governorate, 31527
Noha M.H elkafoury, +0201271040849, nohaelkafoury@dent.tanta.edu.eg
About this study
Official title: Clinical and Laboratory Assessment of 3D Printing Orientation and Film Thickness on the Accuracy and Patient Satisfaction of Maxillary Complete Dentures
This randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Each participant will receive two maxillary 3D-printed complete dentures fabricated using the same printing orientation (0°, 45°, or 90°) with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. The study will compare the influence of these printing parameters on denture accuracy and patient-reported outcomes to identify the optimal 3D printing settings for complete denture fabrication.
Read the detailed description
This prospective randomized crossover clinical trial is designed to evaluate and compare the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients.
The study will include completely edentulous patients requiring maxillary and mandibular complete dentures. Each participant will receive two maxillary complete dentures fabricated using 3D printing technology with the same printing orientation but two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Participants will be randomly allocated to one of three printing orientation groups (0°, 45°, or 90°), with five participants in each group.
The three printing orientations being compared are:
- 0° Build Orientation: Maxillary denture bases will be fabricated at a 0° printing orientation using both 50 μm and 100 μm layer thicknesses.
- 45° Build Orientation: Maxillary denture bases will be fabricated at a 45° printing orientation using both 50 μm and 100 μm layer thicknesses.
- 90° Build Orientation: Maxillary denture bases will be fabricated at a 90° printing orientation using both 50 μm and 100 μm layer thicknesses.
Each participant will wear each denture for a three-month evaluation period. The primary outcomes of the study are trueness of the printed denture bases, assessed by comparing the scanned denture base STL files with the original CAD design, and patient satisfaction, evaluated using a Visual Analogue Scale (VAS) for aesthetics, speech, masticatory efficiency, hygiene, and comfort. Dimensional deviation of the denture bases will also be assessed through three-dimensional superimposition analysis at denture insertion and after three months of use.
The findings of this study will help identify the optimal combination of 3D printing orientation and layer thickness for the fabrication of maxillary complete dentures, contributing to improved manufacturing accuracy and enhanced patient satisfaction with digitally fabricated complete dentures.
Primary Outcome Measures
- Trueness of 3D-printed maxillary complete denture bases Description: To evaluate the trueness of the printed denture bases fabricated using different printing orientations (0°, 45°, and 90°) and layer thicknesses (50 μm and 100 μm). Method of assessment: The STL file of each printed denture base will be scanned using an extraoral scanner and superimposed with the original CAD design to determine trueness. Time Frame: At denture fabrication (before clinical insertion).
- Patient Satisfaction
Description: To compare patient satisfaction with dentures fabricated using different 3D printing orientations and layer thicknesses.
Method of assessment: Visual Analogue Scale (VAS; 0-10) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort.
Time Frame: 15 days after insertion (baseline) and 3 months after insertion of each denture.
Secondary Outcome Measure
Dimensional Deviation of 3D-printed Maxillary Complete Denture Bases
Description: To evaluate the dimensional stability of the denture bases fabricated with different printing orientations and layer thicknesses.
Method of assessment: Three-dimensional superimposition of scanned STL files to visualize and quantify dimensional deviation.
Time Frame: At denture insertion and after 3 months of clinical use for each denture.
- Conditions
- Complete Edentulism, Maxillary Complete Denture Rehabilitation, Prosthodontics, 3d Printing, Digital Denture
- Being tested
- 0° 3D-Printed Maxillary Complete Denture, 45° 3D-Printed Maxillary Complete Denture, 90° 3D-Printed Maxillary Complete Denture
- Keywords
- Digital dentistry, Patient satisfaction, Dimensional accuracy, Denture trueness, Layer thickness, Build orientation, CAD/CAM dentures, Additive manufacturing, Three-dimensional printing, Maxillary complete denture, Complete edentulism
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0° 3D-Printed Maxillary Complete DentureDevice
Participants will receive maxillary complete dentures fabricated using a 0° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 0° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
45° 3D-Printed Maxillary Complete DentureDevice
Participants will receive maxillary complete dentures fabricated using a 45° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 45° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
90° 3D-Printed Maxillary Complete DentureDevice
Participants will receive maxillary complete dentures fabricated using a 90° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 90° build orientation on denture trueness, dimensional deviation, and patient satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| 0° Printing Orientation | Experimental | Participants will receive two maxillary complete dentures fabricated using a 0° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction. Receives: Device: 0° 3D-Printed Maxillary Complete Denture |
| 45° Printing Orientation | Experimental | Participants will receive two maxillary complete dentures fabricated using a 45° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction Receives: Device: 45° 3D-Printed Maxillary Complete Denture |
| 90° Printing Orientation | Experimental | Participants will receive two maxillary complete dentures fabricated using a 90° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction. Receives: Device: 90° 3D-Printed Maxillary Complete Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of 3D-printed maxillary complete denture bases
The trueness of the printed maxillary complete denture bases will be evaluated by comparing the STL file of each scanned denture base with the original CAD design using three-dimensional superimposition analysis.
Measured: immedtiate
Patient satisfaction
Patient satisfaction will be assessed using a 10-point Visual Analogue Scale (VAS) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort after wearing each maxillary complete denture.
Measured: 3 months
Secondary outcomes (1)
Dimensional deviation of 3D-printed maxillary complete denture bases
Dimensional deviation will be evaluated by superimposing the scanned STL files of the denture bases to visually and quantitatively assess three-dimensional deviation after fabrication and clinical use.
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 posted31 Jul 2026
- Study start8 Aug 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Mar 2027 (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 Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly assigned to one of three 3D printing orientation groups (0°, 45°, or 90°). Within each group, each participant will receive two maxillary complete dentures fabricated using the same printing orientation but with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Each denture will be worn for three months before crossing over to the alternate layer thickness. The crossover design allows within-subject comparison of the effect of layer thickness on trueness, dimensional deviation, and patient satisfaction while minimizing inter-participant variability, whereas comparisons among the three groups will evaluate the influence of printing orientation.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mamdouh Hamed Elkafoury, Tanta University
- Investigators
- noha Mamdouh Hamed elkafoury, BDS, MSc, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740278
- Sponsor's protocol ID
- RP-12-24- 2291
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 31 Jul 2026
- 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 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Assessment of 3D Printing Orientation and Film Thickness on the Accuracy and Patient Satisfaction of Maxillary Complete Dentures
- ClinicalTrials.gov ID
- NCT07740278
- Acronym / sponsor ID
- RP-12-24- 2291
- Conditions
- Complete Edentulism, Maxillary Complete Denture Rehabilitation, Prosthodontics, 3d Printing, Digital Denture
- Keywords
- Digital dentistry, Patient satisfaction, Dimensional accuracy, Denture trueness, Layer thickness, Build orientation, CAD/CAM dentures, Additive manufacturing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 8 Aug 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 31 Jul 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 randomized crossover clinical trial aims to evaluate the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients. Each participant will receive two maxillary 3D-printed complete dentures fabricated using the same printing orientation (0°, 45°, or 90°) with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. The study will compare the influence of these printing parameters on denture accuracy and patient-reported outcomes to identify the optimal 3D printing settings for complete denture fabrication.
Detailed description
This prospective randomized crossover clinical trial is designed to evaluate and compare the effect of different three-dimensional (3D) printing orientations and layer thicknesses on the trueness, dimensional accuracy, and patient satisfaction of maxillary complete dentures in completely edentulous patients.
The study will include completely edentulous patients requiring maxillary and mandibular complete dentures. Each participant will receive two maxillary complete dentures fabricated using 3D printing technology with the same printing orientation but two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Participants will be randomly allocated to one of three printing orientation groups (0°, 45°, or 90°), with five participants in each group.
The three printing orientations being compared are:
- 0° Build Orientation: Maxillary denture bases will be fabricated at a 0° printing orientation using both 50 μm and 100 μm layer thicknesses.
- 45° Build Orientation: Maxillary denture bases will be fabricated at a 45° printing orientation using both 50 μm and 100 μm layer thicknesses.
- 90° Build Orientation: Maxillary denture bases will be fabricated at a 90° printing orientation using both 50 μm and 100 μm layer thicknesses.
Each participant will wear each denture for a three-month evaluation period. The primary outcomes of the study are trueness of the printed denture bases, assessed by comparing the scanned denture base STL files with the original CAD design, and patient satisfaction, evaluated using a Visual Analogue Scale (VAS) for aesthetics, speech, masticatory efficiency, hygiene, and comfort. Dimensional deviation of the denture bases will also be assessed through three-dimensional superimposition analysis at denture insertion and after three months of use.
The findings of this study will help identify the optimal combination of 3D printing orientation and layer thickness for the fabrication of maxillary complete dentures, contributing to improved manufacturing accuracy and enhanced patient satisfaction with digitally fabricated complete dentures.
Primary Outcome Measures
- Trueness of 3D-printed maxillary complete denture bases Description: To evaluate the trueness of the printed denture bases fabricated using different printing orientations (0°, 45°, and 90°) and layer thicknesses (50 μm and 100 μm). Method of assessment: The STL file of each printed denture base will be scanned using an extraoral scanner and superimposed with the original CAD design to determine trueness. Time Frame: At denture fabrication (before clinical insertion).
- Patient Satisfaction
Description: To compare patient satisfaction with dentures fabricated using different 3D printing orientations and layer thicknesses.
Method of assessment: Visual Analogue Scale (VAS; 0-10) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort.
Time Frame: 15 days after insertion (baseline) and 3 months after insertion of each denture.
Secondary Outcome Measure
Dimensional Deviation of 3D-printed Maxillary Complete Denture Bases
Description: To evaluate the dimensional stability of the denture bases fabricated with different printing orientations and layer thicknesses.
Method of assessment: Three-dimensional superimposition of scanned STL files to visualize and quantify dimensional deviation.
Time Frame: At denture insertion and after 3 months of clinical use for each denture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three 3D printing orientation groups (0°, 45°, or 90°). Within each group, each participant will receive two maxillary complete dentures fabricated using the same printing orientation but with two different layer thicknesses (50 μm and 100 μm) in a crossover sequence. Each denture will be worn for three months before crossing over to the alternate layer thickness. The crossover design allows within-subject comparison of the effect of layer thickness on trueness, dimensional deviation, and patient satisfaction while minimizing inter-participant variability, whereas comparisons among the three groups will evaluate the influence of printing orientation.
| Arm | Type | Receives |
|---|---|---|
| 0° Printing Orientation | Experimental | Device: 0° 3D-Printed Maxillary Complete DentureParticipants will receive two maxillary complete dentures fabricated using a 0° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction. |
| 45° Printing Orientation | Experimental | Device: 45° 3D-Printed Maxillary Complete DentureParticipants will receive two maxillary complete dentures fabricated using a 45° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction |
| 90° Printing Orientation | Experimental | Device: 90° 3D-Printed Maxillary Complete DentureParticipants will receive two maxillary complete dentures fabricated using a 90° 3D printing orientation. One denture will be printed with a 50 μm layer thickness and the other with a 100 μm layer thickness. Participants will wear each denture for three months in a crossover sequence to evaluate trueness, dimensional deviation, and patient satisfaction. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completely edentulous patients with good local and systemic health.
- Patients age ranging from 50 to 70 years old.
- Patients with adequate inter-arch space.
- Patients with good neuromuscular control.
Key exclusion criteria (3 listed)
- Patients with any oral diseases which may affect denture construction
- Patients with oral parafunctional habits.
- Patients with tempro-mandibular disorders
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 |
|---|---|---|
| 0° 3D-Printed Maxillary Complete DentureParticipants will receive maxillary complete dentures fabricated using a 0° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 0° build orientation on denture trueness, dimensional deviation, and patient satisfaction. | Device | 0° Printing Orientation |
| 45° 3D-Printed Maxillary Complete DentureParticipants will receive maxillary complete dentures fabricated using a 45° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 45° build orientation on denture trueness, dimensional deviation, and patient satisfaction. | Device | 45° Printing Orientation |
| 90° 3D-Printed Maxillary Complete DentureParticipants will receive maxillary complete dentures fabricated using a 90° three-dimensional (3D) printing orientation. Each participant will receive two dentures printed with 50 μm and 100 μm layer thicknesses in a crossover sequence. This intervention is intended to evaluate the effect of the 90° build orientation on denture trueness, dimensional deviation, and patient satisfaction. | Device | 90° Printing Orientation |
Primary outcome
Trueness of 3D-printed maxillary complete denture bases
Time frame: immedtiate
The trueness of the printed maxillary complete denture bases will be evaluated by comparing the STL file of each scanned denture base with the original CAD design using three-dimensional superimposition analysis.
Patient satisfaction
Time frame: 3 months
Patient satisfaction will be assessed using a 10-point Visual Analogue Scale (VAS) evaluating aesthetics, speech, masticatory efficiency, hygiene, and comfort after wearing each maxillary complete denture.
1 secondary outcome
Dimensional deviation of 3D-printed maxillary complete denture bases
Time frame: 3 months
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 31 Jul 2026.
- 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.
noha Mamdouh Hamed elkafoury, BDS, MSc principal investigator
Faculty of Dentistry, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0° 3D-Printed Maxillary Complete Denture, 45° 3D-Printed Maxillary Complete Denture and 90° 3D-Printed Maxillary Complete Denture in people with Complete Edentulism and Maxillary Complete Denture Rehabilitation, run by Tanta 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 3 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 31 Jul 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?
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 noha Mamdouh Hamed elkafoury, BDS, MSc (+201271040849, nohaelkafoury@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trueness of 3D-printed maxillary complete denture bases (time frame: immedtiate). The study lists 2 primary outcomes in all. 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 31 Jul 2026.