Denture,CompleteNCT06588140
Conventional Versus 3D Printing Duplication Techniques of Complete Denture
A study testing Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate., Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin. and Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin. in people with Denture,Complete and Edentulous Alveolar Ridge, run by Ain Shams University at 1 site in Egypt.
Trial summary
Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Denture,Complete, Edentulous Alveolar Ridge
- What is being tested?
- Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate., Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin. and Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Nov 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with old complete dentures without lost vertical dimension.
- Patients with correct centric occluding relation.
- The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability
Who cannot join
- The presence of ridge or soft tissue pathology.
- Diminished saliva production.
- A history of medications affecting saliva quantity or quality.
- Patients with temporomandibular joint problems.
- The presence of sever ridge undercut.
- Debilitated patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial
Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques.
Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.
Read the detailed description
The study will be conducted at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. This within-subject controlled clinical trial will involve twenty completely edentulous patients with old, ill-fitting maxillary complete dentures, who will be selected and recruited following approval by the Research Ethics Committee of the Faculty of Dentistry, Ain Shams University (FDASU-REC). These patients will be rehabilitated with duplicated complete dentures produced through conventional methods and two distinct 3D-printed CAD/CAM techniques.
Group I: The duplication of a refitted complete removable denture will be performed using the conventional heat-cured technique.
Group II: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, where the denture base will be printed separately with pink resin, and the teeth will be printed as a single unit in tooth-colored resin, followed by assembly of the two components.
Group III: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, with the entire denture printed as a single unit in tooth-colored resin, and the denture flange veneered with pink resin.
Outcomes will be evaluated by measuring denture retention with a digital force gauge and occlusal force distribution using the T-Scan system. The collected data will be recorded, tabulated, and subjected to statistical analysis using appropriate tests for group comparisons.
- Conditions
- Denture,Complete, Edentulous Alveolar Ridge
- Being tested
- Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate., Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin., Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.
- Keywords
- CAD-CAM, Complete Dentures, Copying , Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.Device
The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique.
Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.Device
The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed separately with pink polymethyl methacrylate resin, and the teeth are printed as a single unit using tooth-colored resin, followed by the assembly of the two components.
Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.Device
The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink polymethyl methacrylate resin.
| Study group | Role | What they receive |
|---|---|---|
| conventional heat-cured duplication technique. | Active comparator | Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin. Receives: Device: Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate. |
| 3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin | Experimental | Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture base will be printed separately using pink base polymethyl methacrylate resin, and the teeth will be printed as one unit using tooth-colored resin, followed by assembling the two components. Receives: Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin. |
| 3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin | Experimental | Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture will be printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink resin. Receives: Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Retention of maxillary complete denture
The retention of a maxillary complete denture will be assessed using a digital force gauge meter, with retention measurements recorded in Newtons.
Measured: at the time of denture insertion
Secondary outcomes (1)
Evaluation of occlusal force distribution between right and left side
Occlusal force distribution will be assessed using the T-Scan III, with the results expressed as a percentage.
Measured: at the time of denture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Denture,CompleteStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia M. Refai, Ain Shams University
- Investigators
- Amany M Saad Farahat, PHD, Principal investigator, Ain Shams UniveristyYasmine S Elsherbeeny, PHD, Principal investigator, Ain Shams Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588140
- Sponsor's protocol ID
- FDASU-Rec IR032421
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Retention Between Different Duplication Techniques of Complete Dentures: Conventional Versus CAD/CAM: A Within Subject Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06588140
- Acronym / sponsor ID
- FDASU-Rec IR032421
- Conditions
- Denture,Complete, Edentulous Alveolar Ridge
- Keywords
- CAD-CAM, Complete Dentures, Copying , Denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Twenty completely edentulous patients with old, removable dentures with ill-fitting maxillary dentures, proper vertical dimension, and proper occlusion will be recruited for this trial. They will be rehabilitated with duplicated complete dentures manufactured by conventional and two different 3D-printed CAD-CAM Complete Removable Dentures techniques.
Outcomes will be evaluated, including denture retention, which will be evaluated using a digital force gauge, and occlusal force distribution by using a t-scan.
Detailed description
The study will be conducted at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. This within-subject controlled clinical trial will involve twenty completely edentulous patients with old, ill-fitting maxillary complete dentures, who will be selected and recruited following approval by the Research Ethics Committee of the Faculty of Dentistry, Ain Shams University (FDASU-REC). These patients will be rehabilitated with duplicated complete dentures produced through conventional methods and two distinct 3D-printed CAD/CAM techniques.
Group I: The duplication of a refitted complete removable denture will be performed using the conventional heat-cured technique.
Group II: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, where the denture base will be printed separately with pink resin, and the teeth will be printed as a single unit in tooth-colored resin, followed by assembly of the two components.
Group III: The refitted complete denture will be duplicated using a 3D-printed CAD/CAM technique, with the entire denture printed as a single unit in tooth-colored resin, and the denture flange veneered with pink resin.
Outcomes will be evaluated by measuring denture retention with a digital force gauge and occlusal force distribution using the T-Scan system. The collected data will be recorded, tabulated, and subjected to statistical analysis using appropriate tests for group comparisons.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional heat-cured duplication technique. | Active comparator | Device: Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.Duplication of refitted complete removable dentures by conventional heat-cured technique from heat-cured polymethyl methacrylate resin. |
| 3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin | Experimental | Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture base will be printed separately using pink base polymethyl methacrylate resin, and the teeth will be printed as one unit using tooth-colored resin, followed by assembling the two components. |
| 3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin | Experimental | Device: Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.Duplication of a refitted complete removable denture will be produced using a 3D-printed CAD/CAM technique where the denture will be printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink resin. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with old complete dentures without lost vertical dimension.
- Patients with correct centric occluding relation.
- The dentures should be esthetically and functionally satisfactory and exhibit reasonable retention and stability
Key exclusion criteria (6 listed)
- The presence of ridge or soft tissue pathology.
- Diminished saliva production.
- A history of medications affecting saliva quantity or quality.
- Patients with temporomandibular joint problems.
- The presence of sever ridge undercut.
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 |
|---|---|---|
| Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate.The duplication of a refitted complete removable denture will be performed using conventional heat-cured polymethyl methacrylate through the conventional heat-cured polymerization technique. | Device | conventional heat-cured duplication technique. |
| Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin.The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed separately with pink polymethyl methacrylate resin, and the teeth are printed as a single unit using tooth-colored resin, followed by the assembly of the two components. | Device | 3d Printed CAD/CAM duplication technique from Pink polymethyl methacrylate base resin |
| Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin.The duplication of a refitted complete removable denture will be performed using a 3D-printed CAD/CAM technique, where the denture base is printed as a single unit using tooth-colored resin, and the denture flange will be veneered with pink polymethyl methacrylate resin. | Device | 3d Printed CAD/CAM duplication technique from white polymethyl methacrylate base resin |
Primary outcome
Assessment of Retention of maxillary complete denture
Time frame: at the time of denture insertion
The retention of a maxillary complete denture will be assessed using a digital force gauge meter, with retention measurements recorded in Newtons.
1 secondary outcome
Evaluation of occlusal force distribution between right and left side
Time frame: at the time of denture insertion
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 Mar 2025.
Related trials for Denture,Complete
Recruiting
Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
Edentulous Complete Denture Wearers
Recruiting
Nutritional Intervention for Older Adults With Complete Dentures
Edentulism Complete, Denture, Complete
Recruiting
3D Printing Orientation and Film Thickness for Maxillary Complete Dentures
Complete Edentulism, Maxillary Complete Denture Rehabilitation
Active, not recruitingObservational study
Masticatory Efficiency, Bite Force, and Patient-Reported Outcomes in Patients Rehabilitated With Complete and Partial Dentures Supported by Teeth, Mini-Implants, or Conventional Implants
Edentulism, Edentulism Complete
Recruiting
The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life
Edentulism, Complete Dentures
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.
Amany M Saad Farahat, PHD principal investigator
Ain Shams Univeristy
Yasmine S Elsherbeeny, PHD principal investigator
Ain Shams Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duplicated refitted complete denture made from conventionally heat-cured polymethyl methacrylate., Duplicated refitted complete denture made from 3D-printed CAD/CAM pink polymethylmethacrylate acrylic resin. and Duplicated refitted complete denture made from 3D-printed CAD/CAM white polymethylmethacrylate acrylic resin. in people with Denture,Complete and Edentulous Alveolar Ridge, run by Ain Shams 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 3 inclusion and 6 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 Mar 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?
Assessment of Retention of maxillary complete denture (time frame: at the time of denture insertion). 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 Mar 2025; AzTrials last refreshed its copy on 1 Nov 2026.