Tooth Fractures (Class IV)NCT07813949
Evaluation of Clinical Performance, Shade Matching, and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
A study testing Resin Composite Layering Techniques using 3D Printed Casts in people with Tooth Fractures (Class IV) and Composite Resins, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of this randomized clinical trial is to compare different resin composite layering techniques (monochromatic, complex multichromatic, and single-shaded structurally-colored composite) using 3D printed casts for the restoration of Class IV anterior tooth fractures. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Fractures (Class IV), Composite Resins, Permanent Anterior Teeth
- What is being tested?
- Resin Composite Layering Techniques using 3D Printed Casts
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2024to 27 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female patients aged 18 years or older.
- Good oral hygiene and healthy periodontal status.
- Presence of sound adjacent teeth and opposing dentition.
- Patients requiring direct Class IV composite restoration in permanent anterior teeth.
- Cooperative patients willing to comply with the follow-up visits (12 months).
Who cannot join
- Patients with poor oral hygiene or severe systemic diseases.
- Teeth with pulpitis, periapical lesions, or requiring endodontic treatment.
- Presence of severe bruxism, heavy parafunctional habits, or malocclusion.
- Pregnant or lactating females.
- Heavy smokers or patients with active periodontal disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine for Girls, Al-Azhar University
Cairo, Cairo Governorate, 11754
About this study
Official title: Evaluation of the Clinical Performance, Shade Matching and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
The aim of this randomized clinical trial is to compare different resin composite layering techniques (monochromatic, complex multichromatic, and single-shaded structurally-colored composite) using 3D printed casts for the restoration of Class IV anterior tooth fractures. The study will evaluate shade matching, overall clinical performance, and patient satisfaction over a 12-month follow-up period.
Read the detailed description
Restoration of anterior fractured teeth (Class IV) presents an aesthetic and technical challenge in restorative dentistry. While direct composite restorations have traditionally relied on free-hand or conventional putty index techniques, recent advances in digital dentistry allow for 3D digital design software and 3D printed casts to create precise palatal guides and optimize anatomical contours and occlusion.
This prospective clinical trial involves 27 adult patients requiring Class IV restorations. Patients are categorized into three equal intervention groups (n=9 each) based on the application technique and resin composite system used: monochromatic layering, complex multichromatic layering, and single-shaded structurally-colored composite. Primary impressions and digital surface scans will be obtained to design missing tooth structures digitally and fabricate 3D printed models. Restoration shade selection will be conducted using both visual and DSLR digital photography techniques. All clinical restorations will be evaluated at baseline, 3 months, 6 months, and 12 months using FDI criteria for clinical performance and shade matching, alongside self-reported patient satisfaction metrics.
- Being tested
- Resin Composite Layering Techniques using 3D Printed Casts
- Keywords
- Class IV Restoration, Layering Techniques, 3D Printed Cast, Shade Matching, Patient Satisfaction
- Medical subject headings
- Tooth Fractures, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin Composite Layering Techniques using 3D Printed CastsDevice
Application of resin composite restorations on anterior Class IV fractures using three different layering protocols (monochromatic, complex multichromatic, and single-shaded structurally colored composite) guided by 3D printed casts.
| Study group | Role | What they receive |
|---|---|---|
| Monochromatic Layering Group | Active comparator | Teeth restored with light-cured conventional resin composite using monochromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide. Receives: Device: Resin Composite Layering Techniques using 3D Printed Casts |
| Complex Multichromatic Layering Group | Experimental | Teeth restored with light-cured multi-shaded resin composite using complex multichromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide. Receives: Device: Resin Composite Layering Techniques using 3D Printed Casts |
| Single-Shaded Structurally-Colored Layering Group | Experimental | Teeth restored with light-cured single-shaded structurally-colored resin composite layering technique on class IV fractured anterior teeth using a 3D printed cast guide. Receives: Device: Resin Composite Layering Techniques using 3D Printed Casts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shade Matching
Evaluation of color match between the resin composite restoration and adjacent natural tooth structure using visual assessment and DSLR digital photography evaluated by FDI criteria.
Measured: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes (2)
Overall Clinical Performance
Assessment of clinical criteria including marginal adaptation, surface texture, fracture/retention, and anatomical form evaluated according to FDI criteria.
Measured: Baseline, 3 months, 6 months, and 12 months
Patient Satisfaction
Evaluation of patient satisfaction regarding aesthetic appearance, shade match, and overall treatment outcome assessed using the Visual Analog Scale (VAS), where scores range from 0 (completely dissatisfied) to 10 (completely satisfied), with higher scores indicating better satisfaction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start27 Oct 2024
- Primary completion27 Oct 2025
- Study completion27 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Fractures (Class IV)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Ahmed Ezz El Dein Abo Seif, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813949
- Sponsor's protocol ID
- P-OP-24-03
- Other IDs
- OPDEN108-1-li
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Performance, Shade Matching and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
- ClinicalTrials.gov ID
- NCT07813949
- Acronym / sponsor ID
- P-OP-24-03
- Keywords
- Class IV Restoration, Layering Techniques, 3D Printed Cast, Shade Matching, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 10 Sep 2026 (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 aim of this randomized clinical trial is to compare different resin composite layering techniques (monochromatic, complex multichromatic, and single-shaded structurally-colored composite) using 3D printed casts for the restoration of Class IV anterior tooth fractures. The study will evaluate shade matching, overall clinical performance, and patient satisfaction over a 12-month follow-up period.
Detailed description
Restoration of anterior fractured teeth (Class IV) presents an aesthetic and technical challenge in restorative dentistry. While direct composite restorations have traditionally relied on free-hand or conventional putty index techniques, recent advances in digital dentistry allow for 3D digital design software and 3D printed casts to create precise palatal guides and optimize anatomical contours and occlusion.
This prospective clinical trial involves 27 adult patients requiring Class IV restorations. Patients are categorized into three equal intervention groups (n=9 each) based on the application technique and resin composite system used: monochromatic layering, complex multichromatic layering, and single-shaded structurally-colored composite. Primary impressions and digital surface scans will be obtained to design missing tooth structures digitally and fabricate 3D printed models. Restoration shade selection will be conducted using both visual and DSLR digital photography techniques. All clinical restorations will be evaluated at baseline, 3 months, 6 months, and 12 months using FDI criteria for clinical performance and shade matching, alongside self-reported patient satisfaction metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monochromatic Layering Group | Active comparator | Device: Resin Composite Layering Techniques using 3D Printed CastsTeeth restored with light-cured conventional resin composite using monochromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide. |
| Complex Multichromatic Layering Group | Experimental | Device: Resin Composite Layering Techniques using 3D Printed CastsTeeth restored with light-cured multi-shaded resin composite using complex multichromatic layering technique on class IV fractured anterior teeth using a 3D printed cast guide. |
| Single-Shaded Structurally-Colored Layering Group | Experimental | Device: Resin Composite Layering Techniques using 3D Printed CastsTeeth restored with light-cured single-shaded structurally-colored resin composite layering technique on class IV fractured anterior teeth using a 3D printed cast guide. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18 years or older.
- Good oral hygiene and healthy periodontal status.
- Presence of sound adjacent teeth and opposing dentition.
- Patients requiring direct Class IV composite restoration in permanent anterior teeth.
- Cooperative patients willing to comply with the follow-up visits (12 months).
Key exclusion criteria (5 listed)
- Patients with poor oral hygiene or severe systemic diseases.
- Teeth with pulpitis, periapical lesions, or requiring endodontic treatment.
- Presence of severe bruxism, heavy parafunctional habits, or malocclusion.
- Pregnant or lactating females.
- Heavy smokers or patients with active periodontal disease.
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 |
|---|---|---|
| Resin Composite Layering Techniques using 3D Printed CastsApplication of resin composite restorations on anterior Class IV fractures using three different layering protocols (monochromatic, complex multichromatic, and single-shaded structurally colored composite) guided by 3D printed casts. | Device | Complex Multichromatic Layering Group, Monochromatic Layering Group, Single-Shaded Structurally-Colored Layering Group |
Primary outcome
Shade Matching
Time frame: Baseline, 3 months, 6 months, and 12 months
Evaluation of color match between the resin composite restoration and adjacent natural tooth structure using visual assessment and DSLR digital photography evaluated by FDI criteria.
2 secondary outcomes
Overall Clinical Performance
Time frame: Baseline, 3 months, 6 months, and 12 months
Patient Satisfaction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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 Resin Composite Layering Techniques using 3D Printed Casts in people with Tooth Fractures (Class IV) and Composite Resins, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Shade Matching (time frame: Baseline, 3 months, 6 months, and 12 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 11 Sep 2026.