Carious Primary MolarsNCT06897020
Child and Parental Satisfaction of Bioflx Crowns Compared to Zirconia Crowns In Primary Molars
A study testing (Group A: Bioflx crowns) and (Group B: Preformed Zirconia crown in people with Carious Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the child and parents satisfaction of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question[s] it aims to answer : Is there a difference in the child and parents satisfaction levels between BioFlx crowns and zirconia crowns in… Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Primary Molars
- What is being tested?
- (Group A: Bioflx crowns) and (Group B: Preformed Zirconia crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 26 Feb 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 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The Inclusion criteria:
- Children aged four to eight years old who are appearing healthy and free of any systemic disease according to parental history.
- Frankl's positive and definitely positive children.
- Children whose parent or guardian are willing to sign an informed consent.
- Children whose parent or guardian are willing to comply with follow-up visits.
- Primary molars indicated for crowns. • Exclusion criteria:
- <!-- -->
- Children with
Who cannot join
- The Exclusion criteria:
- Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
- Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns.
- Child with parafunctional habits.
- Molars with severe structural loss that may compromise crown retention.
- Presence of malocclusion such as crossbite or scissor bite.
- Primary molar with root caries.
- Primary molar with root resorption or furcation involvement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University.
Giza, Cairo Governorate, 12613
Razan Adil Yousif Ahmed, B.DSc, 00201010118444, Razanadil.14@gmail.com
About this study
Official title: Evaluation Of Child and Parental Satisfaction Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
The goal of this clinical trial is to evaluate the child and parents satisfaction of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question[s] it aims to answer : Is there a difference in the child and parents satisfaction levels between BioFlx crowns and zirconia crowns in the restoration of primary molars?" The study will also assess the clinical performance of both types of crowns in terms of Retention, occlusal wear, gingival health, as well as preparation time.
Read the detailed description
The management of severely decayed primary teeth in pediatric dentistry often requires the use of crowns to restore function and aesthetics. Traditional stainless-steel crowns (SSCs) have been widely used due to their durability and cost-effectiveness; however, their metallic appearance and lack of aesthetic appeal have prompted the development of alternative materials such as zirconia and Bioflx crown. Zirconia crowns are recognized for their superior aesthetics and biocompatibility, making them a preferred choice for parents who prioritize appearance. However, they can present challenges in terms of retention, preparation requirements, and cost. Bioflx crowns, a newer material in pediatric dentistry, aim to combine aesthetic appeal with flexibility and improved adaptability to tooth anatomy. Despite their growing popularity, limited research directly compares the child and parental satisfaction between zirconia and Bioflx crowns. It remains unclear which material offers the best balance of functional, aesthetic, and patient-centered outcomes.This gap in knowledge hinders evidence-based decision-making when selecting crowns for pediatric patients. Zirconia crowns have gained prominence in pediatric dentistry as an alternative to stainless steel crowns for primary molars. While SSCs have long been valued for their durability and ease of placement, their metallic appearance often presents an aesthetic concern for parents and patients. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. One of the main advantages of zirconia crowns is their biocompatibility, as they demonstrate lower plaque accumulation and gingival inflammation. Additionally, zirconia crowns offer superior mechanical properties, including high flexural strength and excellent fracture resistance, making them a long-lasting restorative option. Their wear resistance further supports their use in pediatric patients, particularly those with heavy occlusal forces. This study stems from the need to bridge the gap in current research regarding the satisfaction and the effectiveness associated with Bioflx crowns. Understanding whether Bioflx crowns offer superior aesthetic and functional outcomes compared to Zirconia crowns could influence clinical decision-making in pediatric dentistry. This is especially relevant as parents increasingly seek restorations that provide both durability and a natural appearance for their children.
- Conditions
- Carious Primary Molars
- Being tested
- (Group A: Bioflx crowns), (Group B: Preformed Zirconia crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Group A: Bioflx crowns)Other
prepartion:1.The mesiodistal width of the tooth will be measured using calipers and a closely fitted crown will be selected based on the measurements.
2.The tooth will be prepared similarly to stainless steel crowns (SSCs): • Occlusal reduction of approximately 1-1.5 mm will be done using a diamond bur.Mesial and distal reduction of no more than 1 mm will be performed using a No. 169L diamond bur.Depending on the tooth anatomy, either no buccal and lingual reduction will be needed, or a minimal reduction will be done. 3.All sharp line angles and corners will be smoothed to ensure proper crown fit. 4.The crown will be checked for proper fit before cementation. It will be positioned to extend 1 mm below the gingival margin. 5.The crown will be cemented using luting glass ionomer cement (GIC). The crown will be held with firm, constant pressure until the cement sets initially.
6.The marginal fit will be evaluated, and necessary adjustments will be made. 7.The occlusion will be checked.
(Group B: Preformed Zirconia crownOther
- Crown Selection: The mesiodistal dimension of the corresponding tooth will be measured . to select the appropriate size.
- Occlusal Reduction: The marginal ridge of adjacent teeth will be used as a reference point and a 1.5-2 mm of occlusal reduction will be performed to allow proper crown seating.
- Bucco-Lingual Reduction: The bucco-lingual wall will be reduced by approximately 1-1.5 mm using a flame-shaped diamond bur.
- Interproximal Reduction: 1mm of interproximal reduction will be performed using a flame-shaped diamond bur such as a .368 or .330tapered carbide bur.
- Feather Margin Preparation: Subgingival reduction of 1-2 mm will be done using a flame-shaped diamond bur, creating a feathered margin to achieve a passive fit.
- Trial Fitting of the Crown: The crown will be tried in to ensure proper adaptation. until the crown fits passively and extends sub gingivally by 1-2 mm wit.
- Glass ionomer cement will be used for cementation.
| Study group | Role | What they receive |
|---|---|---|
| (Group A: Performed Bioflx crowns) | Experimental | Bioflx Crowns, claimed to be the first flexible, durable, and aesthetic preformed crowns for primary molars. Bioflx are monochromatic, metal-free, tooth-colored crowns made from a high-strength resin polymer used in the medical device industry, offering strength, flexibility, and durability.These crowns are autoclavable and are claimed to require similar tooth preparation as SSCs. Receives: Other: (Group A: Bioflx crowns) |
| (Group B: Preformed zirconia crown) | Experimental | Zirconia crowns brought a concept shift in esthetics of crowns; they are the most esthetic option available for treating primary molars. These crowns are resilient, tooth-colored, and highly polished. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. Receives: Other: (Group B: Preformed Zirconia crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child and Parents Satisfaction
Method of Measurement:
- 5-Point likert's scale unites of measurement:
- Very Happy.
- Happy.
- Neither.
- Unhappy.
- Very Unhappy.
- Questionnaire:Ordinary or N/A existing validated tool.
Measured: [Time Frame: T (Time): 6months interval T0: 0T1: 3month T2: 6month]
Secondary outcomes (4)
Retention
Measure by Modified United States Public Health System criteria:
Alpha: Intact. Bravo:Chipped/loss of material. Charlie: Complete loss of crown.
Measured: [Time Frame: follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
Occlusal wear of crown
Measure by Modified United States Public Health System criteria:
Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with exposure.
Measured: [Time Frame: T (Time): 6months interval T0: 0 T1: 3 month T2: 6month]
Gingival health
Measure by: Gingival index:
0: healthy gum.
- mild discoloration and edematous gingiva no bleeding on probing.
- red oedematous and shiny gingiva bleeding on probing.
- red oedematous and ulceration gingiva spontaneous bleeding.
Measured: [Time Frame: T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
Preparation time
Measure by :Stopwatch per minutes.
Measured: [Time Frame: baseline]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion26 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carious Primary MolarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Razan Adil Yousif Ahmed, Cairo University
- Investigators
- Prof.Dr. Manal Ahmed Elshiekh, Ph.D, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897020
- Sponsor's protocol ID
- CPS - Bioflx Vs ZR
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.
PubMed 32509626Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.
PubMed 38616425
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Child and Parental Satisfaction Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
- ClinicalTrials.gov ID
- NCT06897020
- Acronym / sponsor ID
- CPS - Bioflx Vs ZR
- Conditions
- Carious Primary Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 26 Feb 2026 (estimated)
- First posted
- 26 Mar 2025 (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.
The goal of this clinical trial is to evaluate the child and parents satisfaction of Bioflx crowns compared to zirconia crowns in the restoration of primary molars. The main question[s] it aims to answer : Is there a difference in the child and parents satisfaction levels between BioFlx crowns and zirconia crowns in the restoration of primary molars?" The study will also assess the clinical performance of both types of crowns in terms of Retention, occlusal wear, gingival health, as well as preparation time.
Detailed description
The management of severely decayed primary teeth in pediatric dentistry often requires the use of crowns to restore function and aesthetics. Traditional stainless-steel crowns (SSCs) have been widely used due to their durability and cost-effectiveness; however, their metallic appearance and lack of aesthetic appeal have prompted the development of alternative materials such as zirconia and Bioflx crown. Zirconia crowns are recognized for their superior aesthetics and biocompatibility, making them a preferred choice for parents who prioritize appearance. However, they can present challenges in terms of retention, preparation requirements, and cost. Bioflx crowns, a newer material in pediatric dentistry, aim to combine aesthetic appeal with flexibility and improved adaptability to tooth anatomy. Despite their growing popularity, limited research directly compares the child and parental satisfaction between zirconia and Bioflx crowns. It remains unclear which material offers the best balance of functional, aesthetic, and patient-centered outcomes.This gap in knowledge hinders evidence-based decision-making when selecting crowns for pediatric patients. Zirconia crowns have gained prominence in pediatric dentistry as an alternative to stainless steel crowns for primary molars. While SSCs have long been valued for their durability and ease of placement, their metallic appearance often presents an aesthetic concern for parents and patients. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. One of the main advantages of zirconia crowns is their biocompatibility, as they demonstrate lower plaque accumulation and gingival inflammation. Additionally, zirconia crowns offer superior mechanical properties, including high flexural strength and excellent fracture resistance, making them a long-lasting restorative option. Their wear resistance further supports their use in pediatric patients, particularly those with heavy occlusal forces. This study stems from the need to bridge the gap in current research regarding the satisfaction and the effectiveness associated with Bioflx crowns. Understanding whether Bioflx crowns offer superior aesthetic and functional outcomes compared to Zirconia crowns could influence clinical decision-making in pediatric dentistry. This is especially relevant as parents increasingly seek restorations that provide both durability and a natural appearance for their children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Group A: Performed Bioflx crowns) | Experimental | Other: (Group A: Bioflx crowns)Bioflx Crowns, claimed to be the first flexible, durable, and aesthetic preformed crowns for primary molars. Bioflx are monochromatic, metal-free, tooth-colored crowns made from a high-strength resin polymer used in the medical device industry, offering strength, flexibility, and durability.These crowns are autoclavable and are claimed to require similar tooth preparation as SSCs. |
| (Group B: Preformed zirconia crown) | Experimental | Other: (Group B: Preformed Zirconia crownZirconia crowns brought a concept shift in esthetics of crowns; they are the most esthetic option available for treating primary molars. These crowns are resilient, tooth-colored, and highly polished. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- The Inclusion criteria:
- <!-- -->
Key exclusion criteria (8 listed)
- The Exclusion criteria:
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 |
|---|---|---|
| (Group A: Bioflx crowns)prepartion:1.The mesiodistal width of the tooth will be measured using calipers and a closely fitted crown will be selected based on the measurements. 2.The tooth will be prepared similarly to stainless steel crowns (SSCs): • Occlusal reduction of approximately 1-1.5 mm will be done using a diamond bur.Mesial and distal reduction of no more than 1 mm will be performed using a No. 169L diamond bur.Depending on the tooth anatomy, either no buccal and lingual reduction will be needed, or a minimal reduction will be done. 3.All sharp line angles and corners will be smoothed to ensure proper crown fit. 4.The crown will be checked for proper fit before cementation. It will be positioned to extend 1 mm below the gingival margin. 5.The crown will be cemented using luting glass ionomer cement (GIC). The crown will be held with firm, constant pressure until the cement sets initially. 6.The marginal fit will be evaluated, and necessary adjustments will be made. 7.The occlusion will be checked. | Other | (Group A: Performed Bioflx crowns) |
| (Group B: Preformed Zirconia crown1. Crown Selection: The mesiodistal dimension of the corresponding tooth will be measured . to select the appropriate size. 2. Occlusal Reduction: The marginal ridge of adjacent teeth will be used as a reference point and a 1.5-2 mm of occlusal reduction will be performed to allow proper crown seating. 3. Bucco-Lingual Reduction: The bucco-lingual wall will be reduced by approximately 1-1.5 mm using a flame-shaped diamond bur. 4. Interproximal Reduction: 1mm of interproximal reduction will be performed using a flame-shaped diamond bur such as a .368 or .330tapered carbide bur. 5. Feather Margin Preparation: Subgingival reduction of 1-2 mm will be done using a flame-shaped diamond bur, creating a feathered margin to achieve a passive fit. 6. Trial Fitting of the Crown: The crown will be tried in to ensure proper adaptation. until the crown fits passively and extends sub gingivally by 1-2 mm wit. 7. Glass ionomer cement will be used for cementation. | Other | (Group B: Preformed zirconia crown) |
Primary outcome
Child and Parents Satisfaction
Time frame: [Time Frame: T (Time): 6months interval T0: 0T1: 3month T2: 6month]
Method of Measurement: * 5-Point likert's scale unites of measurement: 1. Very Happy. 2. Happy. 3. Neither. 4. Unhappy. 5. Very Unhappy. * Questionnaire:Ordinary or N/A existing validated tool.
4 secondary outcomes
Retention
Time frame: [Time Frame: follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
Occlusal wear of crown
Time frame: [Time Frame: T (Time): 6months interval T0: 0 T1: 3 month T2: 6month]
Gingival health
Time frame: [Time Frame: T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
Preparation time
Time frame: [Time Frame: baseline]
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 28 Mar 2025.
- Results publication: PubMed 32509626Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.
- Results publication: PubMed 38616425Patil AS, Jain M, Choubey S, Patil M, Chunawala Y. Comparative evaluation of clinical success of Stainless Steel and Bioflx crowns in primary molar - A 12 month split mouth prospective randomized clinical trial. J Indian Soc Pedod Prev Dent. 2024 Jan 1;42(1):37-45. doi: 10.4103/JISPPD.JISPPD_484_23. Epub 2024 Apr 15.
- Individual participant dataSharing planned: No
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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.
Prof.Dr. Manal Ahmed Elshiekh, Ph.D study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (Group A: Bioflx crowns) and (Group B: Preformed Zirconia crown in people with Carious Primary Molars, run by Cairo University 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Mar 2025. 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?
Contact Razan Adil Yousif Ahmed, Bachelor of dental science (00201010118444, Razanadil.14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Parents Satisfaction (time frame: [Time Frame: T (Time): 6months interval T0: 0T1: 3month T2: 6month]). 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 NCT06897020, which also lists 2 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 28 Mar 2025.