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Zirconia Crowns Versus Extraction of Primary Anterior Teeth

ConditionEarly Childhood Caries (ECC)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorPassant Nagy

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Children aged 3-5 years

Presence of one or more decayed primary anterior teeth

Written informed consent from parent or legal guardian

Disqualifiers

Craniofacial anomalies or genetic syndromes

Diagnosed developmental delay or speech disorders

Previous speech therapy

Systemic disease contraindicating general anaesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zirconia Crown

    Procedure/Surgery

    Restoration of severely mutilated anterior primary teeth using prefabricated zirconia crowns performed.

  • Extraction

    Procedure/Surgery

    Extraction of severely mutilated anterior primary teeth, without anterior prosthetic replacement.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Zirconia Crown Group- Intervention: Restoration of severely mutilated anterior primary teeth using pExperimental treatment 1 intervention
Group B: Extraction Group - Intervention: Extraction of severely mutilated anterior primary teeth, without anActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 month and 3 months

Secondary outcomes

1

1. Parental Satisfaction

* Measure: Structured questionnaire * Scale: 5-point Likert scale * Time Frame: 1 month and 3 months

Time frame
1 month and 3 months
2

2. Child Self-Image

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

Time frame
1 month and 3 months
3

3. Speech Development

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

Time frame
1 month and 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Passant Nagy

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov

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