Zirconia Crowns Versus Extraction of Primary Anterior Teeth

Early childhood caries (ECC) remains one of the most prevalent chronic conditions in preschool children. Management of decayed anterior primary teeth is particularly challenging due to young age, limited cooperation and extensive tooth destruction. As a result, extraction is often selected as a definitive treatment.

However, systematic and rapid reviews have demonstrated associations between premature loss of primary anterior teeth and adverse outcomes, including reduced OHRQoL, speech distortion, altered oral habits and psychosocial impacts. These reviews have consistently highlighted the need for prospective, patient-centred studies employing validated outcome measures and addressing methodological limitations of earlier research.

Prefabricated zirconia crowns have emerged as an aesthetic and durable restorative option for anterior primary teeth. While clinical success and parental acceptance have been reported, direct comparisons with extraction that incorporate patient-centred outcomes and economic evaluation are scarce.

This study addresses these gaps by prospectively comparing zirconia crown restoration and extraction of decayed anterior primary teeth, using validated OHRQoL, parental satisfaction, child self-image and speech development.

Study Design

* Allocation: Non-randomised (controlled clinical study) * Blinding:

Outcome assessors and data analysts/statisticians will be blinded

* Primary Purpose: Treatment * Design Framework: Pragmatic clinical study reflecting routine practice

Enrollment 60 participants

Arms and Interventions Arm 1: Zirconia Crown Group

Intervention:

Restoration of decayed anterior primary teeth using prefabricated zirconia crowns.

Arm 2: Extraction Group

Intervention:

Extraction of decayed anterior primary teeth, without anterior prosthetic replacement.

Allocation Method:

Allocation will be performed based on predefined clinical restorability criteria and shared decision-making with parents or legal guardians. Randomisation will not feasible due to ethical and clinical considerations.

Outcome Measures Primary Outcome Measure Change in Oral Health-Related Quality of Life (OHRQoL)

* Measurement Tool: Early Childhood Oral Health Impact Scale (ECOHIS), parent-reported * Time Frame: Baseline (pre-treatment), 1 month post-treatment, 3 months post-treatment (primary endpoint) * Units: Total score (0-52) and domain scores * Description: Higher scores indicate poorer OHRQoL Secondary Outcome Measures

1. Parental Satisfaction

* Measure: Structured questionnaire * Scale: 5-point Likert scale * Time Frame: 1 month and 3 months 2. Child Self-Image

* Measure: Parent-reported pictorial self-image scale * Units: Composite score * Time Frame: 1 month and 3 months 3. Speech Development

* Measure: Clinical articulation assessment by a calibrated examiner * Units: Presence or absence of articulation concerns * Time Frame: Baseline and 3 months 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

Study Population Preschool children having decayed anterior primary teeth.

Sample Size A total of 60 children (30 per group). Sample size was calculated to detect a clinically meaningful difference in ECOHIS scores with 80% power and a 5% significance level, allowing for attrition.

Statistical Analysis Plan

* Baseline characteristics described using descriptive statistics * Between-group comparisons using parametric or non-parametric tests as appropriate * Longitudinal OHRQoL changes analysed using repeated-measures models * Statistical significance set at p \< 0.05

Ethics and Safety Ethics Approval The study will be submitted to received approval from Ciro University ethics committee.

Informed Consent Written informed consent will be obtained from parents or legal guardians prior to participation.

Safety Considerations All procedures represent standard dental care. No additional risk beyond routine clinical practice will be introduced.

Risk of Bias Management

* Multi-operator pragmatic delivery by non-author clinicians * Automated, anonymised online collection of subjective outcomes * Pre-specified primary endpoint at 3 months * Blinded outcome assessment and statistical analysis

• 1. Parental Satisfaction [Срок оценки: 1 month and 3 months]
• 2. Child Self-Image [Срок оценки: 1 month and 3 months]
• 3. Speech Development [Срок оценки: 1 month and 3 months]