Zirconia Crowns Versus Extraction of Primary Anterior Teeth

NCT07719478 | Not Yet Recruiting

• 1 other identifier: Crowns vs Extraction
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Early Childhood Caries (ECC)

Outcome Measures

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

  1 month and 3 months

Secondary Outcomes (3)

• 1. Parental Satisfaction

  1 month and 3 months

• 2. Child Self-Image

  1 month and 3 months

• 3. Speech Development

  1 month and 3 months

Study Arms (2)

Zirconia Crown Group- Intervention: Restoration of severely mutilated anterior primary teeth using p

EXPERIMENTAL

Restoration of decayed anterior primary teeth using prefabricated zirconia crowns.

Procedure: Zirconia Crown

Extraction Group - Intervention: Extraction of severely mutilated anterior primary teeth, without an

ACTIVE COMPARATOR

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

Procedure: Extraction

Interventions

Extraction PROCEDURE

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

Extraction Group - Intervention: Extraction of severely mutilated anterior primary teeth, without an

Zirconia Crown PROCEDURE

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

Zirconia Crown Group- Intervention: Restoration of severely mutilated anterior primary teeth using p

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-5 years
• Presence of one or more decayed primary anterior teeth
• Written informed consent from parent or legal guardian

You may not qualify if:

• Craniofacial anomalies or genetic syndromes
• Diagnosed developmental delay or speech disorders
• Previous speech therapy
• Systemic disease contraindicating general anaesthesia

Sponsors & Collaborators

• Passant Nagy: lead

Study Officials

• Cairo University Cairo University

  Cairo University

  STUDY CHAIR

Central Study Contacts

Passant Nagi, A. professor

CONTACT

+201120655633; passant.nagi@dentistry.cu.edu.eg

Ahmed Elkhadem, Professor

CONTACT

+01064440888; Ahmed.elkhadem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 22, 2026
• Study Start: July 18, 2026
• Primary Completion: July 30, 2026
• Study Completion: August 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07