Denture HyperplasiadimensionsNCT06959576
Trueness and Dimensional Deviation of 3D Printed Nanocomposite Maxillary Denture Base Resin (In Vivo Study)
A study testing nanoparticles in people with Denture Hyperplasia, run by Tanta University at 1 site in Egypt.
Trial summary
Purpose: To evaluate the effect of adding nano ZrO2 and nano TiO2 nanoparticles on trueness and dimensional deviation of maxillary 3D printed denture base resin on completely edentulous patients. Materials and Methods: This study was carried out on 24 completely edentulous patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Denture Hyperplasia
- What is being tested?
- nanoparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 12 Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients participating in this study were selected according to the following criteria:
- Completely edentulous patients with good local and systemic health.
- With an age range of 50 to 70 years old.
- Have adequate interarch space and class Ⅰ angle classification.
- Have good neuromuscular control. Patient exclusion criteria
- Any disease that may affect denture construction
- Oral parafunctional habits.
- Temporomandibular disorders
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbial and Laboratory Study of 3D-Printed Reinforced Acrylic Denture
Purpose: To evaluate the effect of adding nano ZrO2 and nano TiO2 nanoparticles on trueness and dimensional deviation of maxillary 3D printed denture base resin on completely edentulous patients.
Materials and Methods: This study was carried out on 24 completely edentulous patients. The patients were divided randomly into three equal groups; Group I: Patients received 3D printed maxillary complete denture without additives, Group II: Patients received 3D printed maxillary complete denture reinforced by Nano ZrO2 (0.4%) by Wt and Group III: Patients received 3D printed maxillary complete denture reinforced by Nano TiO2 (0.4%) by Wt. Trueness was evaluated by scanning the denture using an extraoral scanner after the printing process, before insertion. Dimensional deviation was evaluated by scanning the denture using an extraoral scanner at the time of insertion and after 6 months, 12 months, and 18 months. The trueness and dimensional deviation values were analyzed using repeated measure ANOVA, followed by multiple comparison Turkey test.
Read the detailed description
- Primary and final impressions of the maxillary and mandibular arches were taken for each patient following basic prosthetic principles.
- Maxillary and mandibular record blocks were made on the master casts and adjusted in the oral cavity of the patients in a normal manner to ensure an acceptable vertical dimension at occlusion and a freeway space of 2-4 mm. The centric relationship was recorded via the static method.
- An extra-oral scanner was used for scanning master casts (upper and lower), then occlusion blocks on the master cast were scanned after spraying with the scanner spray.
- Master casts and jaw relation records. Standard tessellation language (STL) files were sent to the software platform (Exocad). The software enabled virtually simultaneous mounting and alignment.
- Virtual design of the upper and lower bases and virtual setting of the upper and lower teeth were performed.
- The virtual denture STL file was exported to the LCD printer, which prints the denture base and teeth (trial base) as one unit.
- The try-in step was performed via the trial denture base to check for occlusion, esthetics, and denture border extension.
If any modification was performed on teeth using articulating paper or in the denture base using pressure-indicating paste, the trial denture bases were scanned by an extraoral scanner. The STL file was then sent again to the software for correction of the design, and then sent to the 3D printer software.
- Before printing, each file was checked for support adequacy, the printing orientation was 45 degrees, the thickness of the printed layer was 50 microns, and the printing time was 4 hours and 7 seconds for each denture15
- The denture base and the teeth were printed separately via a 3D printer.16
- For Group Ι, Pink denture base resin was used without nanoparticles for printing the denture bases. However, for Group II, Pink denture base resin reinforced by nanoparticles (ZrO2) (0.4%) by weight was used for printing the denture bases.
- Additionally, for Group III, pink denture base resin reinforced with nanoparticles (TiO2) (0.4%) by weight was used for printing the denture bases.
- For printing the teeth, white tooth resin was used for all groups.
- To remove any residual monomers after printing, the denture bases and teeth were placed in isopropyl alcohol for five minutes.
- Finally, resin was used to attach teeth to recessed pockets in the denture bases, after which the dentures were placed in the postcuring unit.
- Eventually, the dentures were finished, and the teeth were coated with resin glaze to protect and polish areas of posterior pits and fissures and interproximal surfaces from staining or discoloration.
- The dentures were inserted into the patient's mouth and checked for any necessary adjustments, and every patient was given the same post-insertion instructions for home care and follow-up evaluation, and a regular oral and denture hygiene protocol.
- Conditions
- Denture Hyperplasia
- Being tested
- nanoparticles
- Keywords
- 3Dprinted denture base, nanoparticles, trueness, dimensional deviation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoparticlesOther
Also called ZrO2, TiO2
Nanoparticles improve the dimensional stability of 3D printed denture base resin, so preventing instability of the denture over time
| Study group | Role | What they receive |
|---|---|---|
| Nanoparticles | Other | Nanoparticles improve the quality of 3D-printed denture base resin Receives: Other: nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trueness of 3D printing
Scanning of the maxillary denture bases was done using the extraoral scanner.
- Each denture was sprayed by scanning spray and was placed on the scanning table. The STL files were saved for evaluation. The STL file of each 3D printed denture base was compared with the STL file of the original design.
- A 3D analysis software (Medit link) and root mean square (RMS) calculation method were used to evaluate the deviations of the maxillary denture bases when compared with the original STL file. Original STL file and test-STL files were imported into the software, and the original STL was selected as the reference.
- Test-STL was superimposed over the original STL by using the comparison tool of the software, which allows simultaneous selection of 3 points on both files.
- Software automatically calculated overall RMS values; thus, no additional formula was used. Color-difference maps were generated to calculate the RMS values.
Measured: After printing 0 days
Dimensional deviation of maxillary 3D printed denture base resin
Evaluation was carried out during the time of insertion, after 6,12and 18 months.
- Maxillary dentures were placed over an acrylic index and fixed to the rotary table of the desktop scanner by using sticky wax.
- The scanning procedure was done from various angles to obtain both the fitting and polished surface of the denture. The produced STL file from the first scan was saved as a baseline or master file for the subsequent measurements.
- At 6,12, and 18 months, the denture was scanned again, and at each time the resultant STL file was superimposed on the master file to obtain color maps of dimensional deviation using Medit Link software.
- Eight areas of interest for the accuracy evaluation of dentures were defined at the intaglio surface: right and left edentulous crests, right and left buccal flanges, central palate, postdam, and right and left tuberosity, with average points selected from each area.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start15 Feb 2023
- Primary completion30 Jan 2025
- Study completion12 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture HyperplasiaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Teama, Tanta University
- Investigators
- Houda Amin Rashad, prof, Study director, Tanta UniversityEman Mohamed Shakal, prof, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959576
- Sponsor's protocol ID
- RP 2#23 1
- Acronym
- dimensions
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Following the research ethics committee of the faculty of dentistry Tanta university
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial and Laboratory Study of 3D-Printed Reinforced Acrylic Denture
- ClinicalTrials.gov ID
- NCT06959576
- Acronym / sponsor ID
- dimensions / RP 2#23 1
- Conditions
- Denture Hyperplasia
- Keywords
- 3Dprinted denture base, nanoparticles, trueness, dimensional deviation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 6 May 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.
Purpose: To evaluate the effect of adding nano ZrO2 and nano TiO2 nanoparticles on trueness and dimensional deviation of maxillary 3D printed denture base resin on completely edentulous patients.
Materials and Methods: This study was carried out on 24 completely edentulous patients. The patients were divided randomly into three equal groups; Group I: Patients received 3D printed maxillary complete denture without additives, Group II: Patients received 3D printed maxillary complete denture reinforced by Nano ZrO2 (0.4%) by Wt and Group III: Patients received 3D printed maxillary complete denture reinforced by Nano TiO2 (0.4%) by Wt. Trueness was evaluated by scanning the denture using an extraoral scanner after the printing process, before insertion. Dimensional deviation was evaluated by scanning the denture using an extraoral scanner at the time of insertion and after 6 months, 12 months, and 18 months. The trueness and dimensional deviation values were analyzed using repeated measure ANOVA, followed by multiple comparison Turkey test.
Detailed description
- Primary and final impressions of the maxillary and mandibular arches were taken for each patient following basic prosthetic principles.
- Maxillary and mandibular record blocks were made on the master casts and adjusted in the oral cavity of the patients in a normal manner to ensure an acceptable vertical dimension at occlusion and a freeway space of 2-4 mm. The centric relationship was recorded via the static method.
- An extra-oral scanner was used for scanning master casts (upper and lower), then occlusion blocks on the master cast were scanned after spraying with the scanner spray.
- Master casts and jaw relation records. Standard tessellation language (STL) files were sent to the software platform (Exocad). The software enabled virtually simultaneous mounting and alignment.
- Virtual design of the upper and lower bases and virtual setting of the upper and lower teeth were performed.
- The virtual denture STL file was exported to the LCD printer, which prints the denture base and teeth (trial base) as one unit.
- The try-in step was performed via the trial denture base to check for occlusion, esthetics, and denture border extension.
If any modification was performed on teeth using articulating paper or in the denture base using pressure-indicating paste, the trial denture bases were scanned by an extraoral scanner. The STL file was then sent again to the software for correction of the design, and then sent to the 3D printer software.
- Before printing, each file was checked for support adequacy, the printing orientation was 45 degrees, the thickness of the printed layer was 50 microns, and the printing time was 4 hours and 7 seconds for each denture15
- The denture base and the teeth were printed separately via a 3D printer.16
- For Group Ι, Pink denture base resin was used without nanoparticles for printing the denture bases. However, for Group II, Pink denture base resin reinforced by nanoparticles (ZrO2) (0.4%) by weight was used for printing the denture bases.
- Additionally, for Group III, pink denture base resin reinforced with nanoparticles (TiO2) (0.4%) by weight was used for printing the denture bases.
- For printing the teeth, white tooth resin was used for all groups.
- To remove any residual monomers after printing, the denture bases and teeth were placed in isopropyl alcohol for five minutes.
- Finally, resin was used to attach teeth to recessed pockets in the denture bases, after which the dentures were placed in the postcuring unit.
- Eventually, the dentures were finished, and the teeth were coated with resin glaze to protect and polish areas of posterior pits and fissures and interproximal surfaces from staining or discoloration.
- The dentures were inserted into the patient's mouth and checked for any necessary adjustments, and every patient was given the same post-insertion instructions for home care and follow-up evaluation, and a regular oral and denture hygiene protocol.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanoparticles | Other | Other: nanoparticlesNanoparticles improve the quality of 3D-printed denture base resin |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients participating in this study were selected according to the following criteria:
- Completely edentulous patients with good local and systemic health.
- With an age range of 50 to 70 years old.
- Have adequate interarch space and class Ⅰ angle classification.
- Have good neuromuscular control. Patient exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nanoparticlesAlso: ZrO2, TiO2Nanoparticles improve the dimensional stability of 3D printed denture base resin, so preventing instability of the denture over time | Other | Nanoparticles |
Primary outcome
Trueness of 3D printing
Time frame: After printing 0 days
Scanning of the maxillary denture bases was done using the extraoral scanner. * Each denture was sprayed by scanning spray and was placed on the scanning table. The STL files were saved for evaluation. The STL file of each 3D printed denture base was compared with the STL file of the original design. * A 3D analysis software (Medit link) and root mean square (RMS) calculation method were used to evaluate the deviations of the maxillary denture bases when compared with the original STL file. Original STL file and test-STL files were imported into the software, and the original STL was selected as the reference. * Test-STL was superimposed over the original STL by using the comparison tool of the software, which allows simultaneous selection of 3 points on both files. * Software automatically calculated overall RMS values; thus, no additional formula was used. Color-difference maps were generated to calculate the RMS values.
Dimensional deviation of maxillary 3D printed denture base resin
Time frame: 18 months
Evaluation was carried out during the time of insertion, after 6,12and 18 months. * Maxillary dentures were placed over an acrylic index and fixed to the rotary table of the desktop scanner by using sticky wax. * The scanning procedure was done from various angles to obtain both the fitting and polished surface of the denture. The produced STL file from the first scan was saved as a baseline or master file for the subsequent measurements. * At 6,12, and 18 months, the denture was scanned again, and at each time the resultant STL file was superimposed on the master file to obtain color maps of dimensional deviation using Medit Link software. * Eight areas of interest for the accuracy evaluation of dentures were defined at the intaglio surface: right and left edentulous crests, right and left buccal flanges, central palate, postdam, and right and left tuberosity, with average points selected from each area.
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 6 May 2025.
- Individual participant dataSharing planned: No. Following the research ethics committee of the faculty of dentistry Tanta university
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.
Houda Amin Rashad, prof study director
Tanta University
Eman Mohamed Shakal, prof study director
Tanta 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 nanoparticles in people with Denture Hyperplasia, 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 6 May 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?
Trueness of 3D printing (time frame: After printing 0 days). 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 6 May 2025.