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Completed

NCT Number: NCT06205420

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

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.

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Key information

Conditions

Enamel Hypoplasia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypoplasia Developmental Defects of Enamel Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Dentistry Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 1 year

    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.

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

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 16, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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