Complete DentureNCT03354715
Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One
A study testing Rapid prototyping Denture base and Heat Cured Conventional Complete Denture in people with Complete Denture, run by Cairo University at 1 site in Egypt.
Trial summary
Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Complete Denture
- What is being tested?
- Rapid prototyping Denture base and Heat Cured Conventional Complete Denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2017to 1 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranging from 40-70 years.
- Patients who can understand and respond to a written questionnaire in Arabic.
- Cooperative patients
Who cannot join
- Pathological changes of residual ridges.
- Patients with debilitating systemic diseases.
- Patients with xerostomia.
- Patients with flabby and flat ridges.
- Patients with allergy to acrylic resin
- Patient with sever undercuts, or irregular bony exostosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Cairo, 111789
Atef AS Shaker, dr, 23634965, atefshaker@dentistry.cu.edu.eg
About this study
Official title: Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One: Randomized Control Trial
Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.
Read the detailed description
Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.
SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.
Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.
- Conditions
- Complete Denture
- Being tested
- Rapid prototyping Denture base, Heat Cured Conventional Complete Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid prototyping Denture baseDevice
The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.
Heat Cured Conventional Complete DentureDevice
it is the main treatment for most of completely edentoulous Cases
| Study group | Role | What they receive |
|---|---|---|
| Rapid prototyping Denture base | Sham comparator | Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on Receives: Device: Rapid prototyping Denture base |
| Heat Cured Conventional Complete Denture | Sham comparator | Complete Denture using heat cured Denture base using flasking and deflasking method Receives: Device: Heat Cured Conventional Complete Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other
Measured: 3 month
Secondary outcomes (1)
Retention
resistance to tissue away movement using digital force meter and recording the average of 10 reading in one time and compare the results of the two denture
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start20 Apr 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete DentureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mahmoud Youssef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354715
- Sponsor's protocol ID
- 2717
- Status last verified
- Jun 2018
- First submitted
- 30 Jul 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03354715
- Acronym / sponsor ID
- 2717
- Conditions
- Complete Denture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 28 Nov 2017 (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.
Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.
Detailed description
Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.
SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.
Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid prototyping Denture base | Sham comparator | Device: Rapid prototyping Denture baseComplete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on |
| Heat Cured Conventional Complete Denture | Sham comparator | Device: Heat Cured Conventional Complete DentureComplete Denture using heat cured Denture base using flasking and deflasking method |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ranging from 40-70 years.
- Patients who can understand and respond to a written questionnaire in Arabic.
- Cooperative patients
Key exclusion criteria (6 listed)
- Pathological changes of residual ridges.
- Patients with debilitating systemic diseases.
- Patients with xerostomia.
- Patients with flabby and flat ridges.
- Patients with allergy to acrylic resin
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 |
|---|---|---|
| Rapid prototyping Denture baseThe introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost. | Device | Rapid prototyping Denture base |
| Heat Cured Conventional Complete Dentureit is the main treatment for most of completely edentoulous Cases | Device | Heat Cured Conventional Complete Denture |
Primary outcome
Patient Satisfaction
Time frame: 3 month
Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other
1 secondary outcome
Retention
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid prototyping Denture base and Heat Cured Conventional Complete Denture in people with Complete Denture, 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 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 12 Jun 2018. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 3 month). 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 12 Jun 2018.