Primary Molar RestorationNCT07672470
Parent Satisfaction With Zirconia, Bioflx, and 3D-Printed Crowns for Primary Molars
A study testing Zirconia crown, Bioflx crown and 3D printed crown in people with Primary Molar Restoration and Dental Restorations in Children, run by Delta University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Primary Molar Restoration, Dental Restorations in Children
- What is being tested?
- Zirconia crown, Bioflx crown and 3D printed crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Delta university for science and technology
Gamasa, Dakahlia Governorate, 11152
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Zirconia crown, Bioflx crown, 3D printed crown
- Keywords
- zirconia crown, Bioflx crown, 3D printed crown, parent satisfaction, primary molar crowns, full coverage restorations, Esthetic crowns in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crownDevice
Full-coverage prefabricated zirconia crown used for restoration of primary molars in children.
Bioflx crownDevice
Flexible esthetic full-coverage crown used for restoration of primary molars in children.
3D printed crownDevice
Custom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars.
| Study group | Role | What they receive |
|---|---|---|
| Zirconia Crown Group | Experimental | Children receiving zirconia full-coverage crowns for primary molars Receives: Device: Zirconia crown |
| Bioflx Crown Group | Experimental | Children receiving Bioflx full-coverage crowns for primary molars Receives: Device: Bioflx crown |
| 3D-Printed Crown Group | Experimental | Children receiving 3D printed full-coverage crowns for primary molars Receives: Device: 3D printed crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- = 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).
Measured: Immediately after crown placement and at 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Apr 2026
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Molar RestorationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Said Abdelhafez, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672470
- Sponsor's protocol ID
- 026032213
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 18254415Alazmah 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.
PubMed 41516993Almaghrabi 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.
PubMed 36105659
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modern Crown Options for Children: A Comparative Parent Satisfaction Study of Zirconia, Bioflx and 3D Printed Crown for Primary Molars.
- ClinicalTrials.gov ID
- NCT07672470
- Acronym / sponsor ID
- 026032213
- Keywords
- zirconia crown, Bioflx crown, 3D printed crown, parent satisfaction, primary molar crowns, full coverage restorations, Esthetic crowns in children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Zirconia Crown Group | Experimental | Device: Zirconia crownChildren receiving zirconia full-coverage crowns for primary molars |
| Bioflx Crown Group | Experimental | Device: Bioflx crownChildren receiving Bioflx full-coverage crowns for primary molars |
| 3D-Printed Crown Group | Experimental | Device: 3D printed crownChildren receiving 3D printed full-coverage crowns for primary molars |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia crownFull-coverage prefabricated zirconia crown used for restoration of primary molars in children. | Device | Zirconia Crown Group |
| Bioflx crownFlexible esthetic full-coverage crown used for restoration of primary molars in children. | Device | Bioflx Crown Group |
| 3D printed crownCustom made full coverage crown fabricated using digital scanning and 3D printing technology for restoration of primary molars. | Device | 3D-Printed Crown Group |
Primary outcome
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: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Background: PubMed 18254415Champagne 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.
- Background: PubMed 41516993Alazmah 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.
- Background: PubMed 36105659Almaghrabi 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.
- Individual participant dataSharing planned: No. 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
Related trials for Primary Molar Restoration
Not yet recruiting
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
Dental Restorations in Children, Pediatric Dentistry
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Not yet recruiting
Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
Bite Force, Masseter Muscle
Not yet recruiting
Zirconomer-P Versus RMGI for Proximal Restorations in Primary Molars
Dental Caries
Recruiting
Clinical Performance, Streptococcus Mutans Count, and Salivary pH for Cention-N, Zirconomer, and Resin-modified Glass Ionomer in Class I Restoration of Primary Molars
Streptococcus Mutans Count, Salivary pH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crown, Bioflx crown and 3D printed crown in people with Primary Molar Restoration and Dental Restorations in Children, run by Delta University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Satisfaction Score (time frame: Immediately after crown placement and at 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07672470, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.