Edentulism NosNCT04982510
Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT
A study testing complete denture in people with Edentulism Nos, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays. Read more about this study
- Who is it for?
- Ages Up to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Edentulism Nos
- What is being tested?
- complete denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 27 Jun 2023
- 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 Up to 69 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male edentulous patients.
- Cooperative and highly motivated patients.
- Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation
Who cannot join
- Patients with recent extraction less than 3 months ago
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with allergy to resins.
- Pathological changes of residual ridges.
- Patient with sever undercuts, or irregular bony exostosis.
Show all 9Show fewer
- Patients with flabby and flat ridges.
- Patients with medical or psychological conditions that hinder co-operation.
- Patients with class II or III jaw relation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retention of 3D Printed Bases Using Prefabricated Thermoplastic Trays and Conventional Custom Impression Trays: Randomized Controlled Trial
the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.
The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray
- Conditions
- Edentulism Nos
- Being tested
- complete denture
- Keywords
- digital dentures, definitive impression, thermoplastic trays, printed denture, 3D, rapid prototyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete dentureDevice
3D printed complete denture
| Study group | Role | What they receive |
|---|---|---|
| Thermoplastic tray definitive impression | Experimental | Not described Receives: Device: complete denture |
| Conventional tray definitive impression | Active comparator | Not described Receives: Device: complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary complete denture base retention
A loop will be attached to each denture base at the position of geographic center using self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated.
Measured: 2 weeks after denture insertion
Secondary outcomes (1)
Patient satisfaction
patient satisfaction data will be collected through questionnaire and graded by Visual analogue scale for both study arms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start1 Aug 2021
- Primary completion27 May 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism NosStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonal Abdelbaseer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982510
- Sponsor's protocol ID
- 4421
- Status last verified
- Feb 2024
- First submitted
- 15 Jul 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of 3D Printed Bases Using Prefabricated Thermoplastic Trays and Conventional Custom Impression Trays: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04982510
- Acronym / sponsor ID
- 4421
- Conditions
- Edentulism Nos
- Keywords
- digital dentures, definitive impression, thermoplastic trays, printed denture, 3D, rapid prototyping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 27 May 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 29 Jul 2021 (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 aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.
The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermoplastic tray definitive impression | Experimental | Device: complete denture |
| Conventional tray definitive impression | Active comparator | Device: complete denture |
Who may qualify
- Ages
- Up to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Male edentulous patients.
- Cooperative and highly motivated patients.
- Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation
Key exclusion criteria (9 listed)
- Patients with recent extraction less than 3 months ago
- Patients with Parkinson's disease
- Patients with xerostomia.
- Patients with allergy to resins.
- Pathological changes of residual ridges.
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 |
|---|---|---|
| complete denture3D printed complete denture | Device | Conventional tray definitive impression, Thermoplastic tray definitive impression |
Primary outcome
Maxillary complete denture base retention
Time frame: 2 weeks after denture insertion
A loop will be attached to each denture base at the position of geographic center using self cure acrylic resin and the retention will be measured by applying the forces perpendicular to the denture using Digital Force Meter Each base will be tested 3 times and the average will be calculated.
1 secondary outcome
Patient satisfaction
Time frame: 2 weeks
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 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Edentulism Nos
RecruitingObservational study
Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)
Frailty, Malnutrition
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing complete denture in people with Edentulism Nos, 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 3 inclusion and 9 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 8 Feb 2024. 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?
Maxillary complete denture base retention (time frame: 2 weeks after 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 8 Feb 2024.