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

Ain Shams University

Status: Enrolling

Conditions: Enamel Hypoplasia

Treatments: Other: Injectable giomer restoration; Other: Injectable composite resin restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT06205420

FDASU-RecIR012365

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Injectable composite resin restoration

Experimental group

Description:

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

Treatment:

Other: Injectable composite resin restoration

Injectable Giomer restoration

Experimental group

Description:

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

Treatment:

Other: Injectable giomer restoration