Edentulism3D-DENTURENCT07035574
Assessment of Wear and Muscular Efficiency of 3D Printed Versus Conventional Denture Teeth: A Cross-Over In Vivo Study
A study testing Conventional Denture Teeth and 3D Printed Denture Teeth in people with Edentulism, run by Cairo University.
Trial summary
This study aims to evaluate the wear resistance and muscular efficiency of denture teeth fabricated using two different methods: 3D printing and conventional techniques. The research is designed as a crossover in vivo study, where completely edentulous patients will receive both types of dentures sequentially. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Edentulism
- What is being tested?
- Conventional Denture Teeth and 3D Printed Denture Teeth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 May 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients. Aged 21-70 years old. Able to read and sign the informed consent document. Class Ι maxilla-mandibular relationship. Free from temporomandibular disorders. Free from systemic diseases that could affect neuromuscular behaviors or muscular activities.
- Edentulous condition falls within Class I and II cases based on the Prosthodontic Diagnostic Index (PDI) classification system for complete edentulism.
Who cannot join
- Presence of major medical problems or severe chronic diseases. Poor residual ridge anatomy. Any intra-oral soft or hard tissue abnormalities. Flat, flabby, or knife-edge ridge anatomy.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Amount of Wear and Muscular Efficiency of 3D Printed Denture Teeth Versus Conventionally Fabricated Denture Teeth: A Cross-Over In Vivo Study
This study aims to evaluate the wear resistance and muscular efficiency of denture teeth fabricated using two different methods: 3D printing and conventional techniques. The research is designed as a crossover in vivo study, where completely edentulous patients will receive both types of dentures sequentially. The primary outcome is the amount of wear observed in the denture teeth over time, while the secondary outcome is the muscular efficiency measured using electromyography (EMG). The study seeks to determine whether 3D printed denture teeth offer advantages in durability and functionality compared to conventionally fabricated denture teeth. Results from this study may provide valuable insights into improving the quality and comfort of dentures for edentulous patients.
Read the detailed description
Complete dentures are a common treatment option for edentulous patients, providing essential functionality and aesthetics. With advancements in digital dentistry, 3D printing has emerged as a promising technique for fabricating denture teeth, offering potential benefits such as customization, faster production, and improved material properties. However, the long-term performance of 3D printed denture teeth compared to conventionally fabricated teeth remains under investigation.
This study is designed to assess two critical aspects of denture teeth performance: wear resistance and muscular efficiency. Wear resistance refers to the ability of denture teeth to withstand forces during chewing without significant degradation, while muscular efficiency evaluates how effectively the jaw muscles function with the dentures during activities like chewing and speaking.
The study will recruit completely edentulous patients aged 21-70 years from the Prosthodontics Department at Cairo University. Participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. The crossover design allows for direct comparison within the same group of patients, minimizing individual variability.
Primary impressions will be taken, followed by the fabrication of dentures using standardized protocols. The amount of wear will be measured by scanning the denture teeth at delivery and after three months of use. Muscular efficiency will be assessed using electromyography (EMG) to measure bite force at delivery and after three months.
This study is self-funded and conducted under the supervision of the Prosthodontics Department at Cairo University. Ethical approval has been obtained, and all participants will provide informed consent. The findings of this study are expected to contribute to the advancement of prosthodontic practices, offering evidence-based recommendations for the use of 3D printed denture teeth in clinical settings.
- Conditions
- Edentulism
- Being tested
- Conventional Denture Teeth, 3D Printed Denture Teeth
- Keywords
- 3D Printed Denture Teeth, Wear Analysis, Muscular Efficiency, Digital Dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Denture TeethOther
Complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth.
3D Printed Denture TeethOther
Complete dentures fabricated using additive manufacturing techniques with advanced resin materials.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Denture Teeth | Active comparator | Participants will receive complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth. Receives: Other: Conventional Denture Teeth |
| 3D Printed Denture Teeth | Experimental | Participants will receive complete dentures fabricated using 3D printing technology with custom-designed denture teeth. Receives: Other: 3D Printed Denture Teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Wear
The amount of wear observed in denture teeth fabricated using conventional techniques versus 3D printing technology. Denture teeth will be scanned at delivery and after 3 months of use, and the wear will be quantified by comparing the scans.
Measured: 6 months
Secondary outcomes (1)
Muscular Efficiency
Muscular efficiency will be assessed by measuring maximum bite force using electromyography (EMG) at delivery and after 3 months of use. The variation in bite force between conventional and 3D printed denture teeth will be analyzed.
Measured: 6months
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 start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 May 2026 (estimated)
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.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- The study uses a crossover design where participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. This design minimizes individual variability and allows for direct comparison of outcomes.
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuqa alazawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035574
- Sponsor's protocol ID
- TUQA2025DENTURE
- Acronym
- 3D-DENTURE
- Status last verified
- Jun 2025
- First submitted
- 16 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
- Yes: De-identified individual participant data related to primary and secondary outcomes (amount of wear and muscular efficiency). Supporting documentation such as study protocol, statistical analysis plan, and informed consent form.
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
- Assessment of the Amount of Wear and Muscular Efficiency of 3D Printed Denture Teeth Versus Conventionally Fabricated Denture Teeth: A Cross-Over In Vivo Study
- ClinicalTrials.gov ID
- NCT07035574
- Acronym / sponsor ID
- 3D-DENTURE / TUQA2025DENTURE
- Conditions
- Edentulism
- Keywords
- 3D Printed Denture Teeth, Wear Analysis, Muscular Efficiency, Digital Dentistry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- 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.
This study aims to evaluate the wear resistance and muscular efficiency of denture teeth fabricated using two different methods: 3D printing and conventional techniques. The research is designed as a crossover in vivo study, where completely edentulous patients will receive both types of dentures sequentially. The primary outcome is the amount of wear observed in the denture teeth over time, while the secondary outcome is the muscular efficiency measured using electromyography (EMG). The study seeks to determine whether 3D printed denture teeth offer advantages in durability and functionality compared to conventionally fabricated denture teeth. Results from this study may provide valuable insights into improving the quality and comfort of dentures for edentulous patients.
Detailed description
Complete dentures are a common treatment option for edentulous patients, providing essential functionality and aesthetics. With advancements in digital dentistry, 3D printing has emerged as a promising technique for fabricating denture teeth, offering potential benefits such as customization, faster production, and improved material properties. However, the long-term performance of 3D printed denture teeth compared to conventionally fabricated teeth remains under investigation.
This study is designed to assess two critical aspects of denture teeth performance: wear resistance and muscular efficiency. Wear resistance refers to the ability of denture teeth to withstand forces during chewing without significant degradation, while muscular efficiency evaluates how effectively the jaw muscles function with the dentures during activities like chewing and speaking.
The study will recruit completely edentulous patients aged 21-70 years from the Prosthodontics Department at Cairo University. Participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. The crossover design allows for direct comparison within the same group of patients, minimizing individual variability.
Primary impressions will be taken, followed by the fabrication of dentures using standardized protocols. The amount of wear will be measured by scanning the denture teeth at delivery and after three months of use. Muscular efficiency will be assessed using electromyography (EMG) to measure bite force at delivery and after three months.
This study is self-funded and conducted under the supervision of the Prosthodontics Department at Cairo University. Ethical approval has been obtained, and all participants will provide informed consent. The findings of this study are expected to contribute to the advancement of prosthodontic practices, offering evidence-based recommendations for the use of 3D printed denture teeth in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study uses a crossover design where participants will receive two sets of complete dentures: one fabricated using conventional techniques and the other using 3D printing. This design minimizes individual variability and allows for direct comparison of outcomes.
| Arm | Type | Receives |
|---|---|---|
| Conventional Denture Teeth | Active comparator | Other: Conventional Denture TeethParticipants will receive complete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth. |
| 3D Printed Denture Teeth | Experimental | Other: 3D Printed Denture TeethParticipants will receive complete dentures fabricated using 3D printing technology with custom-designed denture teeth. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completely edentulous patients. Aged 21-70 years old. Able to read and sign the informed consent document. Class Ι maxilla-mandibular relationship. Free from temporomandibular disorders. Free from systemic diseases that could affect neuromuscular behaviors or muscular activities.
- Edentulous condition falls within Class I and II cases based on the Prosthodontic Diagnostic Index (PDI) classification system for complete edentulism.
Key exclusion criteria (2 listed)
- Presence of major medical problems or severe chronic diseases. Poor residual ridge anatomy. Any intra-oral soft or hard tissue abnormalities. Flat, flabby, or knife-edge ridge anatomy.
- -
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 |
|---|---|---|
| Conventional Denture TeethComplete dentures fabricated using conventional techniques with prefabricated acrylic denture teeth. | Other | Conventional Denture Teeth |
| 3D Printed Denture TeethComplete dentures fabricated using additive manufacturing techniques with advanced resin materials. | Other | 3D Printed Denture Teeth |
Primary outcome
Amount of Wear
Time frame: 6 months
The amount of wear observed in denture teeth fabricated using conventional techniques versus 3D printing technology. Denture teeth will be scanned at delivery and after 3 months of use, and the wear will be quantified by comparing the scans.
1 secondary outcome
Muscular Efficiency
Time frame: 6months
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 25 Jun 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data related to primary and secondary outcomes (amount of wear and muscular efficiency). Supporting documentation such as study protocol, statistical analysis plan, and informed consent form.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Denture Teeth and 3D Printed Denture Teeth in people with Edentulism, run by Cairo University.
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 2 inclusion and 2 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: opening soon, 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.
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 tuqa s madhi, B.D.S. (+20 1221905983, salahtuqa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of Wear (time frame: 6 months). 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.