NCT06205420

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 8 Years – 14 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Injectable composite resin restoration	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.
DRUG	Injectable giomer restoration	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.
DRUG	Active comparator: Direct composite resin laminate	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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2024-01-16
• Last updated: 2026-02-17

Locations

1 site across 1 country: Egypt