Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children

NCT06205420 | Completed Phase 4

• 1 other identifier: FDASU-RecIR012365
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. Follow up will be done every 6 months for 2 years.

Conditions

Enamel Hypoplasia

Keywords

composite resin restoration; giomer; injectable restorations; injection molding; developmental enamel defects; Permanent Anterior teeth

Outcome Measures

Primary Outcomes (1)

• 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.

  every 6months for 2 years

Secondary Outcomes (2)

• The Mean Annual Failure rate using the World Dental Federation (FDI) criteria.

  1 year

• Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives

  6 months

Study Arms (3)

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.

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.

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.

Drug: Active comparator: Direct composite resin laminate

Interventions

Active comparator: Direct composite resin laminate DRUG

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.

Control: Direct Composite Resin Laminate

Injectable composite resin restoration DRUG

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 composite resin restoration

Injectable giomer restoration DRUG

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.

Injectable Giomer restoration

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

MeSH Terms

Conditions

Dental Enamel Hypoplasia; Developmental Defects of Enamel

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry

Model Details: This treatment involves the use of two different injectable restorations for the esthetic treatment of hypoplastic anterior teeth.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 16, 2024
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)