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

NCT07672470 | Active Not Recruiting

• 1 other identifier: 026032213
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Parent Satisfaction Score

  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

Study Arms (3)

Zirconia Crown Group

EXPERIMENTAL

Children receiving zirconia full-coverage crowns for primary molars

Device: Zirconia crown

Bioflx Crown Group

EXPERIMENTAL

Children receiving Bioflx full-coverage crowns for primary molars

Device: Bioflx crown

3D-Printed Crown Group

EXPERIMENTAL

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

Device: 3D printed crown

Interventions

Zirconia crown DEVICE

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

Zirconia Crown Group

Bioflx crown DEVICE

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

Bioflx Crown Group

3D printed crown DEVICE

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

3D-Printed Crown Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta university for science and technology

Gamasa, Dakahlia Governorate, 11152, Egypt

Location

Related Publications (3)

• Champagne C, Waggoner W, Ditmyer M, Casamassimo PS, MacLean J. Parental satisfaction with preveneered stainless steel crowns for primary anterior teeth. Pediatr Dent. 2007 Nov-Dec;29(6):465-9.

  PMID: 18254415 BACKGROUND

• Alazmah A. Evaluation of Parents and Child Satisfaction Toward Primary Molar Restoration with Preformed Metal Crowns and Its Impact on Child Bullying. Healthcare (Basel). 2025 Dec 26;14(1):62. doi: 10.3390/healthcare14010062.

  PMID: 41516993 BACKGROUND

• Almaghrabi MA, Albadawi EA, Dahlan MA, Aljohani HR, Ahmed NM, Showlag RA. Exploring Parent's Satisfaction and the Effectiveness of Preformed Metal Crowns Fitting by Hall Technique for Carious Primary Molars in Jeddah Region, Saudi Arabia: Findings of a Prospective Cohort Study. Patient Prefer Adherence. 2022 Sep 8;16:2497-2507. doi: 10.2147/PPA.S370159. eCollection 2022.

  PMID: 36105659 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Dentistry Department / Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 29, 2026
• Study Start: April 1, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)