Esthetic RestorationsNCT07180732
Accuracy of Injection Moulding Technique
A study testing Injection moulding technique and Digital smile design in people with Esthetic Restorations, run by NewGiza University at 1 site in Egypt.
Trial summary
To evaluate the discrepancy between the digital smile design (DSD) and the resulting direct composite veneers via Injection Moulding Technique. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Esthetic Restorations
- What is being tested?
- Injection moulding technique and Digital smile design
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 10 Sep 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants requiring smile make-over
- Good oral hygiene
- Compliance
Who cannot join
- Poor oral hygiene
- Need for orthodontic treatment
- Need of full coverage restoration
- Parafunctional habits
- Lack of compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Direct Composite Veneers Using Injection Moulding Technique
To evaluate the discrepancy between the digital smile design (DSD) and the resulting direct composite veneers via Injection Moulding Technique.
Read the detailed description
This study will be aiming at testing the accuracy of the injection moulding technique compared with the digital smile design, therefore improving the outcome of composite veneers for the patients in order to reach more predictable results. Utilizing a quantitative method to assess accuracy of Injection moulding technique is deficient in literature and using a geometrical subtraction software will be an objective method to compare the difference with the digital smile design.
- Conditions
- Esthetic Restorations
- Being tested
- Injection moulding technique, Digital smile design
- Keywords
- Injection moulding, Veneers, Accuracy, Geomagic, resin composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection moulding techniqueProcedure or surgery
A dental technique that uses a transparent silicone index or stent to inject a low-viscosity composite into a pre-planned and approved tooth shape.
Digital smile designDiagnostic test
A modern approach that uses digital imaging, videos, and software to create a customized, virtual 3D model of a patient's ideal smile before any treatment begins
| Study group | Role | What they receive |
|---|---|---|
| Injection moudling technique | Experimental | A dental procedure where a patient-approved tooth shape, established from a diagnostic wax-up, is replicated using a transparent silicone index Receives: Procedure: Injection moulding technique |
| Digital smile design | Other | Baseline smile design Receives: Diagnostic Test: Digital smile design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The root mean square (RMS) values were obtained through the "3D-compare" method followed by comparison at each surface point between the reference digital design desing and the final outcome using injection moulding
Measured: From enrolment to the end of treatment after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 May 2025
- Primary completion31 Aug 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esthetic RestorationsStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewGiza University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Shaalan, NewGiza University
- Investigators
- Omar O Shaalan, PhD, Principal investigator, Associate Professor, Department of conservative dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180732
- Sponsor's protocol ID
- Accuracy of injection mouldong
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to concerns regarding participant privacy and the absence of explicit consent for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Direct Composite Veneers Using Injection Moulding Technique
- ClinicalTrials.gov ID
- NCT07180732
- Acronym / sponsor ID
- Accuracy of injection mouldong
- Conditions
- Esthetic Restorations
- Keywords
- Injection moulding, Veneers, Accuracy, Geomagic, resin composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NewGiza UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 18 Sep 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.
To evaluate the discrepancy between the digital smile design (DSD) and the resulting direct composite veneers via Injection Moulding Technique.
Detailed description
This study will be aiming at testing the accuracy of the injection moulding technique compared with the digital smile design, therefore improving the outcome of composite veneers for the patients in order to reach more predictable results. Utilizing a quantitative method to assess accuracy of Injection moulding technique is deficient in literature and using a geometrical subtraction software will be an objective method to compare the difference with the digital smile design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection moudling technique | Experimental | Procedure: Injection moulding techniqueA dental procedure where a patient-approved tooth shape, established from a diagnostic wax-up, is replicated using a transparent silicone index |
| Digital smile design | Other | Diagnostic Test: Digital smile designBaseline smile design |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants requiring smile make-over
- Good oral hygiene
- Compliance
Key exclusion criteria (5 listed)
- Poor oral hygiene
- Need for orthodontic treatment
- Need of full coverage restoration
- Parafunctional habits
- Lack of compliance
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 |
|---|---|---|
| Injection moulding techniqueA dental technique that uses a transparent silicone index or stent to inject a low-viscosity composite into a pre-planned and approved tooth shape. | Procedure or surgery | Injection moudling technique |
| Digital smile designA modern approach that uses digital imaging, videos, and software to create a customized, virtual 3D model of a patient's ideal smile before any treatment begins | Diagnostic test | Digital smile design |
Primary outcome
Accuracy
Time frame: From enrolment to the end of treatment after 4 weeks
The root mean square (RMS) values were obtained through the "3D-compare" method followed by comparison at each surface point between the reference digital design desing and the final outcome using injection moulding
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 Sep 2025.
- Individual participant dataSharing planned: No. IPD will not be shared due to concerns regarding participant privacy and the absence of explicit consent for data sharing
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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.
Omar O Shaalan, PhD principal investigator
Associate Professor, Department of conservative dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection moulding technique and Digital smile design in people with Esthetic Restorations, run by NewGiza 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 5 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 Sep 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?
Accuracy (time frame: From enrolment to the end of treatment after 4 weeks). 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 Sep 2025.