Retention of 3D Printed DenturesNCT03507179
Retention of Complete Denture Using Rapid Prototyping
A study testing 3d printed denture and conventional dentures in people with Retention of 3D Printed Dentures, run by Cairo University.
Trial summary
Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention of 3D Printed Dentures
- What is being tested?
- 3d printed denture and conventional dentures
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 4 May 2018to 4 Nov 2018
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ranging from 40-70 years.
- Cooperative patients.
- male or female patients
Who cannot join
- Pathological changes of residual ridges.
- Patients with any systemic diseases.
- Patients with xerostomia.
- Patients with flabby and flat ridges.
- Patients with allergy to resins.
- Patient with sever undercuts, or irregular bony exostosis. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retention of Complete Denture Using Rapid Prototyping Versus a Conventional Complete Denture: Cross Over Randomized Control Trial
Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.
For both groups, a preliminary impression will be made \& after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper \& lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.
Read more
For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.
But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.
For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.
Read the detailed description
Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.
- Conditions
- Retention of 3D Printed Dentures
- Being tested
- 3d printed denture, conventional dentures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3d printed dentureOther
construction of a 3d printed denture through a recent method instead of conventional processing
conventional denturesOther
conventional dentures
| Study group | Role | What they receive |
|---|---|---|
| conventional dentures | Placebo comparator | a complete denture made through conventional processing technique Receives: Other: conventional dentures |
| 3d printed dentures | Active comparator | a complete denture made through 3D printing Receives: Other: 3d printed denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
We will Determine the geographic center for upper denture base to measure retention then A loop will be attached to each denture base at the position of geographic center using clear 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. Then the loop will be removed and the denture will finished and polish. Retention will be measured immediately after denture insertion.
Measured: immediately after denture construction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start4 May 2018 (estimated)
- Primary completion4 Oct 2018 (estimated)
- Study completion4 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retention of 3D Printed DenturesStudies 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
- Participant, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lina khalaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507179
- Sponsor's protocol ID
- lina''s protocol
- Status last verified
- Apr 2018
- First submitted
- 2 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- 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 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of Complete Denture Using Rapid Prototyping Versus a Conventional Complete Denture: Cross Over Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03507179
- Acronym / sponsor ID
- lina''s protocol
- Conditions
- Retention of 3D Printed Dentures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 4 May 2018 (estimated)
- Primary completion
- 4 Oct 2018 (estimated)
- Study completion
- 4 Nov 2018 (estimated)
- First posted
- 24 Apr 2018 (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.
Nineteen patients will be selected from the clinic following the inclusion and exclusion criteria. Each one of them will receive two dentures. The first denture will be a conventional complete denture while the second denture will be a complete denture made by Rapid prototyping method.
For both groups, a preliminary impression will be made \& after pouring the primary impression, self-cured acrylic resin trial denture bases with a wax rim will be constructed on the primary casts for the upper \& lower arches for a jaw relation record. A facebow record will be used to mount the upper cast, while the lower cast will be mounted using a centric relation record. Setting of artificial teeth will be performed, then the denture will be tried in patient's mouth. Functional impression will be taken during the try in stage which.
For the first denture, the functional impression will be poured in normal way to obtain the master cast. Then Processing will be done in normal way and the denture will be finished and polished and delivered to the patient.
But for the second denture construction CBCT scanning of the try in with the functional impression will be done to obtain STL file then denture base manufacturing will be done by 3D printing.
For group A and group B Retention will be measured for the upper denture immediately, with a wash out period one month between the two dentures.
Detailed description
Heat processed denture base is the treatment of choice for most of edentulous patients and it is considered as the golden standard and the main comparator for the new techniques. But using Heat Cured Acrylic resin would require many laboratory steps which introduce several errors . Meanwhile, the introduction of rapid prototyping method with high accuracy which eliminates some of the laboratory steps was the reason for choosing it to compare it with the conventional method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dentures | Placebo comparator | Other: conventional denturesa complete denture made through conventional processing technique |
| 3d printed dentures | Active comparator | Other: 3d printed denturea complete denture made through 3D printing |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranging from 40-70 years.
- Cooperative patients.
- male or female patients
Key exclusion criteria (6 listed)
- Pathological changes of residual ridges.
- Patients with any systemic diseases.
- Patients with xerostomia.
- Patients with flabby and flat ridges.
- Patients with allergy to resins.
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 |
|---|---|---|
| 3d printed dentureconstruction of a 3d printed denture through a recent method instead of conventional processing | Other | 3d printed dentures |
| conventional denturesconventional dentures | Other | conventional dentures |
Primary outcome
retention
Time frame: immediately after denture construction
We will Determine the geographic center for upper denture base to measure retention then A loop will be attached to each denture base at the position of geographic center using clear 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. Then the loop will be removed and the denture will finished and polish. Retention will be measured immediately after denture insertion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing 3d printed denture and conventional dentures in people with Retention of 3D Printed Dentures, 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 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: status not confirmed, as of the sponsor's last update on 24 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lina ismail, masters (01092468850, lina.net@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention (time frame: immediately after denture construction). 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 24 Apr 2018.