Injection Molding Technique: a Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children
- Conditions
- Enamel Hypoplasia
- Interventions
- Drug: Injectable composite resin restorationDrug: Injectable giomer restoration
- Registration Number
- NCT06205420
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Injectable composite resin restoration 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. Injectable Giomer restoration 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. Injectable composite resin restoration 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. Injectable Giomer restoration 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.
- Primary Outcome Measures
Name Time Method Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations. 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 Outcome Measures
Name Time Method The Mean Annual Failure rate using the World Dental Federation (FDI) criteria. 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.
Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives 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.
Trial Locations
- Locations (1)
Faculty of Dentistry Ain Shams University
🇪🇬Cairo, Egypt