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

NCT ID: NCT06205420

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Injectable composite resin restoration

The use of injectable GC Gaenial restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria.

Group Type: EXPERIMENTAL

Injectable composite resin restoration

Intervention Type: 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 Giomer restoration

The use injectable beautiful flow giomer restoration in restoring hypoplastic permanent anterior teeth and the evaluation of its clinical performance using FDI criteria.

Group Type: EXPERIMENTAL

Injectable giomer restoration

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Nour Wahba

Lecturer of Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FDASU-RecIR012365

Identifier Type: -

Identifier Source: org_study_id