Complete DentureNCT06520280
Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture
A study testing polyamide and 3D printed complete denture in people with Complete Denture, run by Ibrahim Mohamed Ali Ibrahim Abd Elrahman at 1 site in Egypt.
Trial summary
The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Complete Denture
- What is being tested?
- polyamide and 3D printed complete denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Feb 2023to Jun 2025
- 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous male patients ranging from age 45 to 60 years.
- Angle's Class I skeletal relationship.
- Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
- Last extraction took place six months ago.
- Normal facial symmetry.
- Cooperative patients.
Who cannot join
- Temporomandibular disorders.
- Uncontrolled diabetes.
- Flabby tissues or sharp mandibular residual ridge.
- Smokers.
- Patients with neuromuscular disorders.
- Patients on chemotherapy or radiotherapy.
- Severe psychiatric disorders.
- Angle's class II and III skeletal relationship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture Bases Construction Techniques: an in Vivo Study
The objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.
Read the detailed description
completely edentulous male patients will be selected from the out patient clinic of Removable Prosthodontic Department, Faculty of Oral and Dental medicine Al-Azhar University (Boys), Cairo, Egypt. patients will be selected and divided into randomly two equal groups and each patient will receive two sets of complete dentures: Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed. Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval. Patient satisfaction will be measured for all patients after 1 and 3 months follow up through a validated questionnaire. Masticatory efficiency will be measured by measuring muscle activity of the masseter and anterior fibers of the temporalis muscle on both sides for both dentures at one week, one month and three months after delivery using electromyography with three types of test foods. Microbial adhesion Samples will be collected one month after delivery of dentures, swaps will be taken from the fitting palatal surface of the upper denture, this will be done immediately after removal of the denture.
- Conditions
- Complete Denture
- Being tested
- polyamide and 3D printed complete denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyamide and 3D printed complete dentureOther
pts. receive 2 sets of complete dentures made from polyamide and 3d printed to use
| Study group | Role | What they receive |
|---|---|---|
| GroupI | Other | First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Receives: Other: polyamide and 3D printed complete denture |
| Group II | Other | First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed Receives: Other: polyamide and 3D printed complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval.
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 posted25 Jul 2024
- Study start13 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (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.
- 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
- Model description
- Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ibrahim Mohamed Ali Ibrahim Abd Elrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ibrahim Mohamed Ali Ibrahim Abd Elrahman, Al-Azhar University
- Investigators
- mohamed helal, professor, Study director, AZU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520280
- Sponsor's protocol ID
- 875/281
- Status last verified
- Jul 2024
- First submitted
- 21 Jul 2024
- Last updated
- 25 Jul 2024
- 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 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Injection Molding and Additive Manufacturing Complete Denture Bases Construction Techniques: an in Vivo Study
- ClinicalTrials.gov ID
- NCT06520280
- Acronym / sponsor ID
- 875/281
- Conditions
- Complete Denture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ibrahim Mohamed Ali Ibrahim Abd ElrahmanUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Jul 2024 (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 objective of the trial is to compare between of polyamide and rapidly prototyped (3D-printed) complete denture bases regarding retention, patient satisfaction, masticatory efficiency and microbial adhesion.
Detailed description
completely edentulous male patients will be selected from the out patient clinic of Removable Prosthodontic Department, Faculty of Oral and Dental medicine Al-Azhar University (Boys), Cairo, Egypt. patients will be selected and divided into randomly two equal groups and each patient will receive two sets of complete dentures: Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed. Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval. Patient satisfaction will be measured for all patients after 1 and 3 months follow up through a validated questionnaire. Masticatory efficiency will be measured by measuring muscle activity of the masseter and anterior fibers of the temporalis muscle on both sides for both dentures at one week, one month and three months after delivery using electromyography with three types of test foods. Microbial adhesion Samples will be collected one month after delivery of dentures, swaps will be taken from the fitting palatal surface of the upper denture, this will be done immediately after removal of the denture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Group I: First, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. Group II: First, patients will receive maxillary and mandibular complete dentures constructed by 3D printed
| Arm | Type | Receives |
|---|---|---|
| GroupI | Other | Other: polyamide and 3D printed complete dentureFirst, patients will receive maxillary and mandibular complete dentures constructed by polyamide thermoplastic resin. |
| Group II | Other | Other: polyamide and 3D printed complete dentureFirst, patients will receive maxillary and mandibular complete dentures constructed by 3D printed |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Completely edentulous male patients ranging from age 45 to 60 years.
- Angle's Class I skeletal relationship.
- Well-developed ridge with U-shaped palatal vault and adequate firm mucosa.
- Last extraction took place six months ago.
- Normal facial symmetry.
Key exclusion criteria (8 listed)
- Temporomandibular disorders.
- Uncontrolled diabetes.
- Flabby tissues or sharp mandibular residual ridge.
- Smokers.
- Patients with neuromuscular disorders.
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 |
|---|---|---|
| polyamide and 3D printed complete denturepts. receive 2 sets of complete dentures made from polyamide and 3d printed to use | Other | Group II, GroupI |
Primary outcome
retention
Time frame: 6 months
Retention will be measured for all patients at delivery day, one month after delivery and three months after delivery. After that, there will be 2 weeks as a period of rest and the two groups will be reversed with reassessment at the same time interval.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- comparison of retention between maxillary milled and conventional denture bases: A clinical study.Link provided by the sponsor.
- Accuracy and retention of denture base fabricated by heat curing and additive manufacturing.Link provided by the sponsor.
- Comparison between Retention of Maxillary Acrylic and Nylon Denture Base Materials.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Complete Denture
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Comparison of Conventional and Face Scan in Recording the Vertical Dimension of Completely Edentulous Patients
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Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
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Clinical and Radiographic Evaluation of Using Regular Versus Narrow Diameter Dental Implantto Support Mandibular Complete Over Denture
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Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
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Nutritional Intervention for Older Adults With Complete Dentures
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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.
mohamed helal, professor study director
AZU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyamide and 3D printed complete denture in people with Complete Denture, run by Ibrahim Mohamed Ali Ibrahim Abd Elrahman 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 6 inclusion and 8 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 25 Jul 2024. 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?
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?
retention (time frame: 6 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 25 Jul 2024.