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NCT Number: NCT07672470

Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Delta university for science and technology

Gamasa, Dakahlia Governorate, 11152, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Zirconia crown

Device

Full-coverage prefabricated zirconia crown used for restoration of primary molars in children.

Bioflx crown

Device

Flexible esthetic full-coverage crown used for restoration of primary molars in children.

3D printed crown

Device

Custom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars.

Primary outcomes

  1. Parent Satisfaction Score

    Time frame: 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:

    • = Very dissatisfied
    • = Dissatisfied
    • = Neutral
    • = Satisfied
    • = 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).

Sponsors and collaborators

Lead sponsor

Delta University for Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.