Edentulous JawNCT06164366
Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees
A study testing 0 degrees 3D printed upper complete dentures and 45 degrees 3D printed upper complete dentures in people with Edentulous Jaw, run by Cairo University.
Trial summary
This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- 0 degrees 3D printed upper complete dentures and 45 degrees 3D printed upper complete dentures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients above the age of 40
- Patients with opposing full natural dentition or completely or partially edentulous arches
- Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
- Cooperative patients that are willing to attend all follow-up periods.
- Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
- 6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes
Who cannot join
- Patients with any temporomandibular joint disorder or parafunctional habits
- Patients with flabby or flat ridges
- Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
- Patients with a history of allergy to dentures made of resins.
- Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
- Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
About this study
Official title: Patient Satisfaction and Adaptation of Maxillary Resin Dentures Printed at 0 Versus 45 Degrees Build Angle: A Randomized Pilot Cross-over Clinical Trial
This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.
Read the detailed description
This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention
- Conditions
- Edentulous Jaw
- Being tested
- 0 degrees 3D printed upper complete dentures, 45 degrees 3D printed upper complete dentures
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 degrees 3D printed upper complete denturesDevice
3d printed dentures at a build angle of 0 degrees
45 degrees 3D printed upper complete denturesDevice
3d printed dentures at a build angle of 45 degrees
| Study group | Role | What they receive |
|---|---|---|
| 0 Degrees Group | Experimental | dentures will be printed at a 0 degrees build angle Receives: Device: 0 degrees 3D printed upper complete dentures |
| 45 Degrees Group | Active comparator | dentures will be printed at a 45 degrees build angle Receives: Device: 45 degrees 3D printed upper complete dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Measured through a questionnaire using a likert scale from 1 - 5 with 1 being extremely satisfied with the intervention and 5 being extremely satisfied with the intervention
Measured: 6 months
denture adaptation
measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation
Measured: 4 weeks
Secondary outcomes (1)
Denture retention
Measured using Kapur scoring system. The grading will follow a Scoring System with four possible scores for retention from least (0) to best retention (3)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Abd-ElWahab Radi, PhD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164366
- Sponsor's protocol ID
- 245326677
- Status last verified
- Dec 2023
- First submitted
- 6 Aug 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Adaptation of Maxillary Resin Dentures Printed at 0 Versus 45 Degrees Build Angle: A Randomized Pilot Cross-over Clinical Trial
- ClinicalTrials.gov ID
- NCT06164366
- Acronym / sponsor ID
- 245326677
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Dec 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.
This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.
Detailed description
This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0 Degrees Group | Experimental | Device: 0 degrees 3D printed upper complete denturesdentures will be printed at a 0 degrees build angle |
| 45 Degrees Group | Active comparator | Device: 45 degrees 3D printed upper complete denturesdentures will be printed at a 45 degrees build angle |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients above the age of 40
- Patients with opposing full natural dentition or completely or partially edentulous arches
- Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
- Cooperative patients that are willing to attend all follow-up periods.
- Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
Key exclusion criteria (6 listed)
- Patients with any temporomandibular joint disorder or parafunctional habits
- Patients with flabby or flat ridges
- Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
- Patients with a history of allergy to dentures made of resins.
- Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
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 |
|---|---|---|
| 0 degrees 3D printed upper complete dentures3d printed dentures at a build angle of 0 degrees | Device | 0 Degrees Group |
| 45 degrees 3D printed upper complete dentures3d printed dentures at a build angle of 45 degrees | Device | 45 Degrees Group |
Primary outcome
patient satisfaction
Time frame: 6 months
Measured through a questionnaire using a likert scale from 1 - 5 with 1 being extremely satisfied with the intervention and 5 being extremely satisfied with the intervention
denture adaptation
Time frame: 4 weeks
measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation
1 secondary outcome
Denture retention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
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Not yet recruitingObservational study
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Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 0 degrees 3D printed upper complete dentures and 45 degrees 3D printed upper complete dentures in people with Edentulous Jaw, 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 6 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 11 Dec 2023. 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. 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?
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?
patient satisfaction (time frame: 6 months). The study lists 2 primary outcomes in all. 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 11 Dec 2023.