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Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary Molars

23 juni 2026 bijgewerkt door: Ahmed Said Abdelhafez, Delta University for Science and Technology

Modern Crown Options for Children: A Comparative Parent Satisfaction Study of Zirconia, Bioflx and 3D Printed Crown for Primary Molars.

This study will compare parent satisfaction with three different types of dental crowns used to restore primary (baby) molars in children: zirconia crowns, Bioflx crowns, and 3D-printed crowns.

Children between 3 and 7 years of age who need a full-coverage restoration of a primary molar will be invited to participate. Participants will be randomly assigned to receive one of the three crown types. All crowns will be placed by the same dentist using standardized treatment procedures.

After treatment, parents will be asked to complete a questionnaire about their satisfaction with the crown. The questionnaire will evaluate several aspects, including the crown's appearance, size, shape, color, durability, and overall satisfaction. Parent satisfaction will be assessed immediately after crown placement and again one month later.

The purpose of this study is to determine whether there are differences in parent satisfaction among these three crown options. The results may help dentists and families make informed decisions when choosing esthetic full-coverage restorations for primary teeth.

Studie Overzicht

Gedetailleerde beschrijving

Dental caries remains one of the most common chronic diseases affecting children worldwide. When primary molars are extensively damaged by caries, full-coverage restorations are often indicated to restore function, maintain arch integrity, and preserve the tooth until its natural exfoliation. Traditionally, stainless steel crowns have been widely used for this purpose; however, increasing parental demand for esthetic restorations has led to the development and adoption of alternative crown materials.

Zirconia crowns have gained popularity because of their excellent esthetics, biocompatibility, and durability. Bioflx crowns have emerged as another esthetic option that offers flexibility and ease of placement. More recently, advances in digital dentistry and additive manufacturing have introduced 3D-printed crowns as a potential restorative solution, allowing for customized fabrication and improved esthetic outcomes.

Although these crown systems are increasingly utilized in pediatric dentistry, limited evidence is available regarding parental satisfaction with these treatment options. Parent perception plays an important role in treatment acceptance, adherence to dental recommendations, and overall evaluation of treatment success. Understanding parental preferences and satisfaction may assist clinicians in selecting restorative materials that meet both clinical requirements and family expectations.

This randomized clinical trial is designed to compare parent satisfaction among zirconia crowns, Bioflx crowns, and 3D-printed crowns used for the restoration of primary molars. Eligible children requiring full-coverage restoration of a primary molar will be randomly allocated to one of the three treatment groups. Crown placement procedures will be standardized and performed by the same operator to minimize variability.

Parent satisfaction will be assessed using a structured questionnaire evaluating crown shape, size, color, durability, and overall satisfaction. Assessments will be performed immediately after treatment and at one-month follow-up. The findings of this study may contribute to evidence-based decision making regarding esthetic full-coverage restorations in pediatric dentistry and provide information about factors influencing parental acceptance of different crown types.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Dakahlia Governorate
      • Gamasa, Dakahlia Governorate, Egypte, 11152
        • Delta University for Science and Technology

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Indication for full-coverage restoration. Cooperative behavior classified as positive or definitely positive according to the Frankl behavior rating scale.

Parent or legal guardian willing to provide informed consent and agree to random allocation to one of the study groups.

Child medically fit to receive routine dental treatment.

Exclusion Criteria:

  • Children requiring advanced behavior management techniques such as sedation or general anesthesia.

Presence of significant systemic medical conditions that may affect oral health or treatment outcomes.

History of failed crown restoration on the same tooth. Teeth with extensive structural destruction that prevents placement of any of the study crown types.

Uncooperative behavior (Frankl negative or definitely negative).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Zirconia Crown Group
Children receiving zirconia full-coverage crowns for primary molars
Full-coverage prefabricated zirconia crown used for restoration of primary molars in children.
Experimenteel: Bioflx Crown Group
Children receiving Bioflx full-coverage crowns for primary molars
Flexible esthetic full-coverage crown used for restoration of primary molars in children.
Experimenteel: 3D-Printed Crown Group
Children receiving 3D printed full-coverage crowns for primary molars
Custom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Parent Satisfaction Score
Tijdsspanne: Immediately after crown placement and at 1 month follow up

Parent satisfaction with the pediatric crown restoration will be assessed using a structured 5-point Likert scale questionnaire. The questionnaire evaluates satisfaction with crown shape, size, color, durability, and overall appearance.

Each item is scored as follows:

  1. = Very dissatisfied
  2. = Dissatisfied
  3. = Neutral
  4. = Satisfied
  5. = Very satisfied

The primary outcome is the mean parent satisfaction score across the evaluated domains for each crown type (zirconia, Bioflx, and 3D-printed crowns).

Immediately after crown placement and at 1 month follow up

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 april 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 juli 2026

Studieregistratiedata

Eerst ingediend

23 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2026

Eerst geplaatst (Werkelijk)

29 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be publicly shared to ensure confidentiality and compliance with ethical approval requirements. Only summarized and de-identified data will be available through publications and presentations

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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