Enamel Hypoplasia Clinical Trial
Official title:
Injection Molding Technique: A Minimally Invasive Management for Enamel Hypoplasia Affecting Permanent Anterior Teeth in Children A Randomized Clinical Trial
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2025 |
Est. primary completion date | November 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 14 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical performance using World Dental Federation (FDI) criteria for evaluating direct restorations. | 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. | every 6months for 2 years | |
Secondary | The Mean Annual Failure rate using the World Dental Federation (FDI) criteria. | 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. | 1 year | |
Secondary | Measuring the impact of enamel hypoplasia on children's daily life from children's and parents' perspectives | 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. | 6 months |
Status | Clinical Trial | Phase | |
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Completed |
NCT04685889 -
Resin Infiltration Treatment for MIH
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N/A |