Edentulous MouthNCT05834530
Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.
A study testing 3D Printed Complete Dentures in people with Edentulous Mouth, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- 3D Printed Complete Dentures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Dec 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa
- All patients accepting prosthodontic treatment by an removable denture.
Who cannot join
- TMJ disorder.
- Limited mouth opening or mandibular movement
- Muscle spasm or tenderness
- Mandibular deviation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electromyographic Activity, Accuracy, Patient Satisfaction and Retention of Conventional Versus 3-D Printed Maxillary Complete Denture: A Cross-over Randomized Controlled Trial
Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.
- Conditions
- Edentulous Mouth
- Being tested
- 3D Printed Complete Dentures
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed Complete DenturesOther
Denture bases printed from a pre-polymerized block via additive technique, using photon S desktop 3D printer* that relies on SLA technology and post cured by post curing unit.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Complete Denture | No intervention | Not described |
| 3 D printed Complete Denture | Experimental | Not described Receives: Other: 3D Printed Complete Dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Retention
Retention was measured for both groups using the universal testing machine. Modification in each denture was made where two small metal tubes (3 mm diameters) were placed a few millimeters above the laterals in maxillary dentures by self-cure acrylic resin. The distance between the right tube and the geometric center was almost the same distance as between the left tube and the geometric center. The exact distance was checked using an orthodontic wire.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Dec 2021
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Kabeel, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834530
- Sponsor's protocol ID
- REC-PD-22-21
- Status last verified
- Apr 2023
- First submitted
- 22 Jan 2023
- Last updated
- 28 Apr 2023
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Activity, Accuracy, Patient Satisfaction and Retention of Conventional Versus 3-D Printed Maxillary Complete Denture: A Cross-over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05834530
- Acronym / sponsor ID
- REC-PD-22-21
- Conditions
- Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Apr 2023 (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.
Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Complete Denture | No intervention | – |
| 3 D printed Complete Denture | Experimental | Other: 3D Printed Complete Dentures |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa
- All patients accepting prosthodontic treatment by an removable denture.
Key exclusion criteria (4 listed)
- TMJ disorder.
- Limited mouth opening or mandibular movement
- Muscle spasm or tenderness
- Mandibular deviation
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 Complete DenturesDenture bases printed from a pre-polymerized block via additive technique, using photon S desktop 3D printer* that relies on SLA technology and post cured by post curing unit. | Other | 3 D printed Complete Denture |
Primary outcome
Change of Retention
Time frame: 3 months
Retention was measured for both groups using the universal testing machine. Modification in each denture was made where two small metal tubes (3 mm diameters) were placed a few millimeters above the laterals in maxillary dentures by self-cure acrylic resin. The distance between the right tube and the geometric center was almost the same distance as between the left tube and the geometric center. The exact distance was checked using an orthodontic wire.
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 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
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Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
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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.
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 3D Printed Complete Dentures in people with Edentulous Mouth, run by Al-Azhar 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 2 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: finished, as of the sponsor's last update on 28 Apr 2023. 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?
Change of Retention (time frame: 3 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 28 Apr 2023.