Edentulous Alveolar RidgeretentionNCT07061860
To Evaluate the Complete Mandibular Dentures Produced Via 3D Printing in Comparison to Those Constructed From Metal-reinforced Acrylic Resin Regarding Their Retention
A study testing digital complete denture and metal reinforced complete denture in people with Edentulous Alveolar Ridge, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- digital complete denture and metal reinforced complete denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2022to 7 Jan 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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Class I maxillary-mandibular relationship
- well-maintained oral mucosa
- normal salivary flow
Who cannot join
- smokers patient
- patient had any abnormalities in hard or soft tissues
- severe ridge undercut
- patient received radiation therapy to the head and neck region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Retention of Mandibular Denture Bases Three-dimensional (3D) Printing Technique and Metal-reinforced Acrylic Resin
in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures
Read the detailed description
the complete denture is constructed for completely edentulous patient. the different technique of construction aim to increase retention of denture to prevent dislodgment during mastication
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- digital complete denture, metal reinforced complete denture
- Keywords
- digital denture, retention, metal reinforced denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital complete dentureDevice
different method of denture construction
metal reinforced complete dentureDevice
different method of denture construction
| Study group | Role | What they receive |
|---|---|---|
| complete edentulous patient receive 3D printed denture | Experimental | group 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures Receives: Device: digital complete denture |
| complete edentulous patient receive metal reinforced denture | Active comparator | group 2: 10 patients: complete denture constructed from metal reinforced acrylic denture Receives: Device: metal reinforced complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention measurement
To assess retention, a digital force gauge (Digital Force Gauge EXTECH 475044) was employed. All of the mandibular dentures were modified to receive a custom-made metal framework consisting of three tubes connected by a hook at the determining geometric center of the denture, two tubes extend 2 cm above the occlusal plane from the retromolar pad region, and one was made at the midline region lingual and below the central incisors. The mandibular denture's polished surface was then joined to the specially constructed custom-made metal framework using self-curing acrylic resin
Measured: immediatlly after denture construction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start7 Jul 2022
- Primary completion7 Jan 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Parallel groups
- Model description
- randomozied controlled parallel double blinding study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Fathy Farouk El-Awadi, National Research Centre, Egypt
- Investigators
- Ayman F Elawady, Ass prof, Principal investigator, National research center, cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061860
- Sponsor's protocol ID
- 8887082022
- Acronym
- retention
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Retention of Mandibular Denture Bases Three-dimensional (3D) Printing Technique and Metal-reinforced Acrylic Resin
- ClinicalTrials.gov ID
- NCT07061860
- Acronym / sponsor ID
- retention / 8887082022
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- digital denture, retention, metal reinforced denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 11 Jul 2025 (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.
in this study we will construct denture for patient by different way and material one of this denture constructed digitally and the other one constructed in conventional way with metal reinforced. then we will measure the retention of the dentures
Detailed description
the complete denture is constructed for completely edentulous patient. the different technique of construction aim to increase retention of denture to prevent dislodgment during mastication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomozied controlled parallel double blinding study
| Arm | Type | Receives |
|---|---|---|
| complete edentulous patient receive 3D printed denture | Experimental | Device: digital complete denturegroup 1: 10 patients: Complete dentures constructed from poly-methyl methacrylate resin were used to create the mandibular and maxillary 3D-printed dentures |
| complete edentulous patient receive metal reinforced denture | Active comparator | Device: metal reinforced complete denturegroup 2: 10 patients: complete denture constructed from metal reinforced acrylic denture |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Class I maxillary-mandibular relationship
- well-maintained oral mucosa
- normal salivary flow
Key exclusion criteria (4 listed)
- smokers patient
- patient had any abnormalities in hard or soft tissues
- severe ridge undercut
- patient received radiation therapy to the head and neck region
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 |
|---|---|---|
| digital complete denturedifferent method of denture construction | Device | complete edentulous patient receive 3D printed denture |
| metal reinforced complete denturedifferent method of denture construction | Device | complete edentulous patient receive metal reinforced denture |
Primary outcome
retention measurement
Time frame: immediatlly after denture construction
To assess retention, a digital force gauge (Digital Force Gauge EXTECH 475044) was employed. All of the mandibular dentures were modified to receive a custom-made metal framework consisting of three tubes connected by a hook at the determining geometric center of the denture, two tubes extend 2 cm above the occlusal plane from the retromolar pad region, and one was made at the midline region lingual and below the central incisors. The mandibular denture's polished surface was then joined to the specially constructed custom-made metal framework using self-curing acrylic resin
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 18 Jul 2025.
- Individual participant dataSharing planned: No. no plan to share
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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.
Ayman F Elawady, Ass prof principal investigator
National research center, cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital complete denture and metal reinforced complete denture in people with Edentulous Alveolar Ridge, run by National Research Centre, Egypt 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 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 18 Jul 2025. 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?
retention measurement (time frame: immediatlly after denture construction). 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 18 Jul 2025.