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Not Yet Recruiting NCT07719478

Zirconia Crowns Versus Extraction of Primary Anterior Teeth

Conditions: Early Childhood Caries (ECC)

Sex: All
Ages: 3 Years – 5 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Passant Nagy

Summary

Severely mutilated anterior primary teeth in preschool children are frequently managed by extraction. However, premature loss of anterior primary teeth has been associated with adverse functional, developmental and psychosocial outcomes, including impaired oral health-related quality of life (OHRQoL), speech concerns and negative self-image. Prefabricated zirconia crowns offer an aesthetic and durable restorative alternative for compromised anterior primary teeth. Despite increasing clinical use, comparative evidence evaluating zirconia crown restoration versus extraction under equivalent conditions using validated patient-centred, developmental and economic outcomes remains limited. This pragmatic, prospective, non-randomised controlled clinical study aims to compare zirconia crown restoration and extraction of severely mutilated anterior primary teeth performed under GA in preschool children. Outcomes include OHRQoL, parental satisfaction, child self-image, and speech development.

Eligibility Criteria

Inclusion Criteria: * Children aged 3-5 years * Presence of one or more decayed primary anterior teeth * Written informed consent from parent or legal guardian Exclusion Criteria: * Craniofacial anomalies or genetic syndromes * Diagnosed developmental delay or speech disorders * Previous speech therapy * Systemic disease contraindicating general anaesthesia

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07719478). StuddyBuddy aggregates publicly available trial information.