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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07672470
Enrollment
90
Registered
2026-06-29
Start date
2026-04-01
Completion date
2026-07-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Molar Restoration, Dental Restorations in Children

Keywords

zirconia crown, Bioflx crown, 3D printed crown, parent satisfaction, primary molar crowns, full coverage restorations, Esthetic crowns in children

Brief summary

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.

Detailed description

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.

Interventions

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

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

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

Sponsors

Delta University for Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

This study uses a three-arm parallel-group randomized design. Eligible children will be randomly assigned in a 1:1:1 ratio to receive one of three full-coverage crown types: zirconia crowns, Bioflx crowns, or 3D-printed crowns. Each participant will receive only one type of crown, and outcomes will be compared between the three independent groups. All interventions will be performed under standardized clinical protocols by the same operator to minimize procedural variability. Parent satisfaction will be assessed after treatment and at one-month follow-up using a structured questionnaire.

Eligibility

Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Parent Satisfaction ScoreImmediately after crown placement and at 1 month follow upParent 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).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026