Rapid Prototyping in DenturesNCT04025697
Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques
A study testing Complete Denture and Rapid prototyped denture in people with Rapid Prototyping in Dentures, run by Cairo University.
Trial summary
The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures. PICOT Format: P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rapid Prototyping in Dentures
- What is being tested?
- Complete Denture and Rapid prototyped denture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 30 Oct 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranging from 40-70 years.
- Cooperative patients with no history of psychological diseases.
- Completely edentulous patients with types I, II and III mandibles according to McGarry et al.
Who cannot join
- Pathological changes of residual ridges
- Patients with xerostomia.
- Patients with flabby ridges.
- Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques: A Randomized Controlled Trial
The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.
PICOT Format:
P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.
O:
Primary Outcome: Denture tooth movement
Secondary outcomes:
- Amount of occlusal adjustments needed
- Chairside time T: Three months with a wash-up period of 2 weeks
- Conditions
- Rapid Prototyping in Dentures
- Being tested
- Complete Denture, Rapid prototyped denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete DentureOther
A conventional CD will be constructed
Rapid prototyped dentureOther
A 3d printed complete denture will be constructed
| Study group | Role | What they receive |
|---|---|---|
| Conventional CD | Placebo comparator | A conventional Complete denture will be constructed and the amount of denture tooth movement will be measured Receives: Other: Complete Denture |
| Rapid Prototyped Denture | Active comparator | A digital light processed denture will be constructed and the amount of tooth movement will be measured Receives: Other: Rapid prototyped denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of tooth movement
The amount of tooth movement will be measured immediately after denture construction using the Geomagic surface matching software (Geomagic Control 2014; 3D Systems Inc.) Laser scan images of the denture obtained both after trial setup of teeth and of the final denture after being hydrated for 24 hours. Those images will be transferred into STL files that will then be superimposed using the global registration function of the software by finding 10,000 points in common between both pre and pot processing STL files.
Measurements will be made at different points using the software and colour surface maps will be created using the 3D comparison function to display the amount and direction of tooth movement
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Prototyping in 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaymaa Belety, Cairo University
- Investigators
- Iman A Radi, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025697
- Sponsor's protocol ID
- Rapid Prototyping Dentures
- Status last verified
- Jul 2019
- First submitted
- 17 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04025697
- Acronym / sponsor ID
- Rapid Prototyping Dentures
- Conditions
- Rapid Prototyping in Dentures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 19 Jul 2019 (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 purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.
PICOT Format:
P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.
O:
Primary Outcome: Denture tooth movement
Secondary outcomes:
- Amount of occlusal adjustments needed
- Chairside time T: Three months with a wash-up period of 2 weeks
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional CD | Placebo comparator | Other: Complete DentureA conventional Complete denture will be constructed and the amount of denture tooth movement will be measured |
| Rapid Prototyped Denture | Active comparator | Other: Rapid prototyped dentureA digital light processed denture will be constructed and the amount of tooth movement will be measured |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranging from 40-70 years.
- Cooperative patients with no history of psychological diseases.
- Completely edentulous patients with types I, II and III mandibles according to McGarry et al.
Key exclusion criteria (4 listed)
- Pathological changes of residual ridges
- Patients with xerostomia.
- Patients with flabby ridges.
- Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease
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 DentureA conventional CD will be constructed | Other | Conventional CD |
| Rapid prototyped dentureA 3d printed complete denture will be constructed | Other | Rapid Prototyped Denture |
Primary outcome
The amount of tooth movement
Time frame: 8 months
The amount of tooth movement will be measured immediately after denture construction using the Geomagic surface matching software (Geomagic Control 2014; 3D Systems Inc.) Laser scan images of the denture obtained both after trial setup of teeth and of the final denture after being hydrated for 24 hours. Those images will be transferred into STL files that will then be superimposed using the global registration function of the software by finding 10,000 points in common between both pre and pot processing STL files. Measurements will be made at different points using the software and colour surface maps will be created using the 3D comparison function to display the amount and direction of tooth movement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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.
Iman A Radi study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Complete Denture and Rapid prototyped denture in people with Rapid Prototyping in 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 4 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 22 Jul 2019. 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 Shaymaa M Belety (+201224101002, sbelety@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The amount of tooth movement (time frame: 8 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 22 Jul 2019.