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

Delta University for Science and Technology

Status: Active, not recruiting

Conditions: Primary Molar Restoration; Dental Restorations in Children

Treatments: Device: Zirconia crown; Device: Bioflx crown; Device: 3D printed crown

Study type: Interventional

Funder types: Other

Identifiers

NCT07672470

026032213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Zirconia Crown Group

Experimental group

Description:

Children receiving zirconia full-coverage crowns for primary molars

Treatment:

Device: Zirconia crown

Bioflx Crown Group

Experimental group

Description:

Children receiving Bioflx full-coverage crowns for primary molars

Treatment:

Device: Bioflx crown

3D-Printed Crown Group

Experimental group

Description:

Children receiving 3D printed full-coverage crowns for primary molars

Treatment:

Device: 3D printed crown