Enamel HypoplasiaPhase 4NCT06205420
Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children
A Phase 4 study testing Injectable composite resin restoration, Injectable giomer restoration and Active comparator: Direct composite resin laminate in people with Enamel Hypoplasia, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Enamel Hypoplasia
- What is being tested?
- Injectable composite resin restoration, Injectable giomer restoration and Active comparator: Direct composite resin laminate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Dec 2024
- Phase
- Phase 4
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I).
- Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index.
- Maxillary and mandibular permanent anterior teeth
Who cannot join
- Refusal of the parents to sign the informed consent.
- Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth.
- Enamel hypomineralization
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry Ain Shams University
Cairo, Cairo Governorate, 11566
About this study
Official title: Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children A Randomized Clinical Trial
This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.
Read the detailed description
The aim of this study is to evaluate and compare the two-year clinical performance of injectable giomer restoration to an injectable composite resin restoration using the injection molding technique for veneering permanent maxillary and mandibular anterior teeth affected with enamel hypoplasia in children using the FDI criteria.
Injection molding technique using injectable composite resin restoration and injectable giomer restoration will be implemented for the esthetic management of permanent anterior teeth affected with enamel hypoplasia in children after removal of the defective enamel, its etching and bonding. Evaluation of their performance will be done using FDI criteria and will be followed up for 2 years.
- Conditions
- Enamel Hypoplasia
- Being tested
- Injectable composite resin restoration, Injectable giomer restoration, Active comparator: Direct composite resin laminate
- Keywords
- composite resin restoration, giomer, injectable restorations, injection molding, developmental enamel defects, Permanent Anterior teeth
- Medical subject headings
- Dental Enamel Hypoplasia, Developmental Defects of Enamel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable composite resin restorationDrug
The teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD.
A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and highly filled flowable composite will be injected in the accurately positioned transparent clear stent through the small channels created by the tip of the restoration syringe in the incisal edge to restore the affected teeth.
Curing will be done on the incisal and labial aspects for 20 seconds and will be repeated after clear stent removal for additional 20 seconds. After removal of the clear stent from the patient's mouth, the restoration sprue as well as excess polymerized restoration will be scrapped off with a scalpel.
Injectable giomer restorationDrug
The teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD.
A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and an injectable giomer restoration will be injected in the accurately positioned transparent clear stent through the small channels created by the tip of the restoration syringe in the incisal edge to restore the affected teeth.
Curing will be done on the incisal and labial aspects for 20 seconds and will be repeated after clear stent removal for additional 20 seconds. After removal of the clear stent from the patient's mouth, the restoration sprue as well as excess polymerized restoration will be scrapped off with a scalpel.
Active comparator: Direct composite resin laminateDrug
The teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD. A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and direct composite resin laminate will be done free hand on these teeth. Curing will be done for 40 seconds, finishing and polishing will be executed thereafter using scalpel and finishing burs and stones. These teeth will be evaluated clinically by FDI criteria at 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Injectable composite resin restoration | Experimental | The use of injectable GC Gaenial restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria. Receives: Drug: Injectable composite resin restoration |
| Injectable Giomer restoration | Experimental | The use injectable beautiful flow giomer restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria. Receives: Drug: Injectable giomer restoration |
| Control: Direct Composite Resin Laminate | Active comparator | Direct composite resin laminate will be placed by direct layering on anterior teeth affected with enamel hypoplasia and evaluated for its clinical performance by the FDI criteria. Receives: Drug: Active comparator: Direct composite resin laminate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.
Clinical performance of an injectable giomer compared to composite restoration in permanent anterior teeth with enamel hypoplasia evaluated by FDI criteria to assess the quality of direct restorations. These are divided into functional, biological, esthetic, and miscellaneous properties. The functional properties assess the fracture of material, its retention, the marginal adaptation, the proximal contact point, the form and contour, the occlusion and wear of dental restorations. The biological assess the presence of recurrent caries, the hard dental tissue defect at the restoration margin, postoperative hypersensitivity and pulpal status, while the esthetic evaluates surface luster and texture, marginal staining, and color match. The miscellaneous examines the patient's perspective of the restoration and the radiographic appearance of the restorations. Every domain assessed is given a score from 1-5, where 1 indicates a clinically excellent property and 5 a clinically poor property.
Measured: every 6months for 2 years
Secondary outcomes (2)
The Mean Annual Failure rate using the World Dental Federation (FDI) criteria.
Calculate the mean annual failure rate or the normalized failure index of the injectable giomer restoration versus the injectable composite resin restoration using the injection molding technique via the FDI criteria. This can be done by several ways: 1) dividing the total failure rate by the number of observation years, 2) using different mathematical formulas given by the FDI for its measurement.
Measured: 1 year
Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives
Evaluate the impact of enamel hypoplasia on children's life by assessing the oral-health-related quality of life of the treated children before and after treatment using the parental perception, family impact scale questionnaires (P-CPQ and FIS) and child perception questionnaire (CPQ-8-10/ 11-14). The former assess the oral symptoms, functional limitation, and social wellbeing of children from their parents' perspectives and the impact their teeth have on the families' daily life, while the latter assesses the same domains but from the children's perspectives. These are scored from 0-4 according to the answers given by the children and parents, where 0 indicates that 'never', 1 'once or twice', 2 'sometimes', 3 'often' and 4 'every day'. Measuring these questionnaires before and after treatment shows the effect of treatment on their quality of life. A total score is gathered for each domain in the questionnaire and is compared to the scores obtained after 6 months.
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 posted16 Jan 2024
- Study start1 Nov 2022
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enamel HypoplasiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This treatment involves the use of two different injectable restorations for the esthetic treatment of hypoplastic anterior teeth.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Wahba, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205420
- Sponsor's protocol ID
- FDASU-RecIR012365
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2023
- Last updated
- 17 Feb 2026
- 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06205420
- Acronym / sponsor ID
- FDASU-RecIR012365
- Conditions
- Enamel Hypoplasia
- Keywords
- composite resin restoration, giomer, injectable restorations, injection molding, developmental enamel defects, Permanent Anterior teeth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Jan 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.
This study aims to evaluate and compare the clinical performance of the injectable giomer restoration versus an injectable composite resin restoration using the injection molding technique for veneering hypoplastic permanent maxillary and mandibular anterior teeth using the FDI criteria. Follow up will be done every 6 months for 2 years.
Detailed description
The aim of this study is to evaluate and compare the two-year clinical performance of injectable giomer restoration to an injectable composite resin restoration using the injection molding technique for veneering permanent maxillary and mandibular anterior teeth affected with enamel hypoplasia in children using the FDI criteria.
Injection molding technique using injectable composite resin restoration and injectable giomer restoration will be implemented for the esthetic management of permanent anterior teeth affected with enamel hypoplasia in children after removal of the defective enamel, its etching and bonding. Evaluation of their performance will be done using FDI criteria and will be followed up for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This treatment involves the use of two different injectable restorations for the esthetic treatment of hypoplastic anterior teeth.
| Arm | Type | Receives |
|---|---|---|
| Injectable composite resin restoration | Experimental | Drug: Injectable composite resin restorationThe use of injectable GC Gaenial restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria. |
| Injectable Giomer restoration | Experimental | Drug: Injectable giomer restorationThe use injectable beautiful flow giomer restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria. |
| Control: Direct Composite Resin Laminate | Active comparator | Drug: Active comparator: Direct composite resin laminateDirect composite resin laminate will be placed by direct layering on anterior teeth affected with enamel hypoplasia and evaluated for its clinical performance by the FDI criteria. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy patients: Class I according to the American Society of Anaesthesiologists (ASA class I).
- Teeth scored code 3 according to Modified Developmental Defects of enamel (mDDE) index.
- Maxillary and mandibular permanent anterior teeth
Key exclusion criteria (3 listed)
- Refusal of the parents to sign the informed consent.
- Signs and symptoms of reversible or irreversible pulpitis, as well as necrosis affecting the permanent anterior teeth.
- Enamel hypomineralization
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 |
|---|---|---|
| Injectable composite resin restorationThe teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD. A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and highly filled flowable composite will be injected in the accurately positioned transparent clear stent through the small channels created by the tip of the restoration syringe in the incisal edge to restore the affected teeth. Curing will be done on the incisal and labial aspects for 20 seconds and will be repeated after clear stent removal for additional 20 seconds. After removal of the clear stent from the patient's mouth, the restoration sprue as well as excess polymerized restoration will be scrapped off with a scalpel. | Drug | Injectable composite resin restoration |
| Injectable giomer restorationThe teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD. A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and an injectable giomer restoration will be injected in the accurately positioned transparent clear stent through the small channels created by the tip of the restoration syringe in the incisal edge to restore the affected teeth. Curing will be done on the incisal and labial aspects for 20 seconds and will be repeated after clear stent removal for additional 20 seconds. After removal of the clear stent from the patient's mouth, the restoration sprue as well as excess polymerized restoration will be scrapped off with a scalpel. | Drug | Injectable Giomer restoration |
| Active comparator: Direct composite resin laminateThe teeth affected with enamel hypoplasia will be prepared by removing all defective enamel to place the restorations on sound tooth structure as recommended by the IAPD. A tooth-by-tooth approach will be employed, where adjacent teeth will be isolated with Teflon tape before selective enamel etching. Selective etching of cut enamel will be done for 15 seconds using 37% phosphoric acid gel. Self-etch adhesive system will be used and direct composite resin laminate will be done free hand on these teeth. Curing will be done for 40 seconds, finishing and polishing will be executed thereafter using scalpel and finishing burs and stones. These teeth will be evaluated clinically by FDI criteria at 6 and 12 months. | Drug | Control: Direct Composite Resin Laminate |
Primary outcome
Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations.
Time frame: every 6months for 2 years
Clinical performance of an injectable giomer compared to composite restoration in permanent anterior teeth with enamel hypoplasia evaluated by FDI criteria to assess the quality of direct restorations. These are divided into functional, biological, esthetic, and miscellaneous properties. The functional properties assess the fracture of material, its retention, the marginal adaptation, the proximal contact point, the form and contour, the occlusion and wear of dental restorations. The biological assess the presence of recurrent caries, the hard dental tissue defect at the restoration margin, postoperative hypersensitivity and pulpal status, while the esthetic evaluates surface luster and texture, marginal staining, and color match. The miscellaneous examines the patient's perspective of the restoration and the radiographic appearance of the restorations. Every domain assessed is given a score from 1-5, where 1 indicates a clinically excellent property and 5 a clinically poor property.
2 secondary outcomes
The Mean Annual Failure rate using the World Dental Federation (FDI) criteria.
Time frame: 1 year
Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives
Time frame: 6 months
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 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Enamel Hypoplasia
RecruitingObservational study
Retention of Pits and Fissure Sealants on Non Carious vs Initial Carious Enamel Lesions in Posterior Teeth
Dental Enamel, Dental Enamel Hypomineralization
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 Phase 4 study testing Injectable composite resin restoration, Injectable giomer restoration and Active comparator: Direct composite resin laminate in people with Enamel Hypoplasia, run by Ain Shams 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 3 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 17 Feb 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations. (time frame: every 6months for 2 years). 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 17 Feb 2026.