Carious Primary MolarsNCT06968767
Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
A study testing bioflx crown and zirconia crown in people with Carious Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial. Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients. 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?
- bioflx crown and zirconia crown
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2025to 16 Jun 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
- Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.
- Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
- Children whose parent or guardian is willing to sign an informed consent.
- Children whose parent or guardian are willing to comply with follow-up visits.
- Frankl's positive and definitely positive patient.
Who cannot join
- Molars with severe structural loss that may compromise crown retention.
- Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
- Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.
- Children with any systemic conditions or disabilities that may affect their ability to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
halah M alshaeri, Bachelor of Dental surgery contact
Egypt1 site
Faculty of Dentistry Cairo University
Cairo, Egypt, 12613
faculty of dentistry cairo university, 0020223642705, rec@dentistry.cu.edu.eg
hala mosaed ali alshaeri, bachelore of dental science
About this study
Official title: Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.
- Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.
- Secondary Objectives:
Read more
To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:
Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.
the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?
Read the detailed description
In pediatric dentistry, achieving efficient and aesthetic restoration of primary molars remains a significant challenge, particularly when treating young or anxious patients who may struggle with long or complex procedures. Zirconia crowns are widely used due to their durability, excellent biocompatibility, and natural tooth-like appearance, making them the gold standard for full-coverage aesthetic restorations in children. However, their placement involves extensive tooth preparation, which results in longer chair time and an increased risk of pulp exposure. These factors can negatively impact both treatment outcomes and patient behavior management.
Bioflex crowns have emerged as a potential alternative, offering a more flexible and user-friendly design that simplifies placement and reduces the amount of tooth preparation required. This may result in shorter procedure times and improved patient comfort. Despite these potential benefits, there is currently limited clinical evidence comparing the preparation time and efficiency of Bioflex crowns versus zirconia crowns for restoring primary molars.
This gap in knowledge makes it difficult for clinicians to make fully informed decisions about which crown system offers the best balance of procedural efficiency, aesthetics, and patient cooperation. By directly comparing Bioflex and zirconia crowns in terms of tooth preparation time and overall clinical practicality, the proposed study aims to determine whether Bioflex crowns provide a significant advantage in pediatric settings. The results could help identify the most time-efficient and effective restorative option for primary molars, ultimately improving care outcomes for pediatric patients.
- Conditions
- Carious Primary Molars
- Being tested
- bioflx crown, zirconia crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioflx crownOther
(Group A: Preformed Biofix Crown - Assigned Intervention)
Crown Selection \& Tooth Preparation:
Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers.
Perform 1-1.5 mm occlusal reduction using a tapered diamond bur.
Reduce proximal areas by approximately 0.5 mm to clear the contact area.
Crown Placement \& Cementation:
Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating.
Final Adjustments \& Cleanup:
Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.
zirconia crownOther
Group B: Preformed Zirconia Crown - Assigned Intervention)
Crown Selection:
Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts.
Tooth Preparation:
Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur.
Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish.
Perform a 1-2 mm subgingival preparation in passively placed fissure bur.
Crown Placement \& Passive Fit Check:
Place the selected crown on the prepared tooth.
Cementation of the Crown:
Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.
| Study group | Role | What they receive |
|---|---|---|
| group A performed bioflx crown | Experimental | (Nu smile, united state) introduced Biofix Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Biofix Crowns are monochromatic, metal-free, tooth-colored crowns made up of high-strength resin polymer used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are like SSC in tooth preparation as claimed by the manufacturer. Their flexibility and snap-fit technology aim to improve retention while minimizing trauma during placement. Receives: Other: bioflx crown |
| group B performed zirconia crown | Experimental | NuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation.
NuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians. Receives: Other: zirconia crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
prepration time
measured by stop watch per minutes
Measured: time frame: T0: 0 basline, follow up 12 month
Secondary outcomes (4)
Occlusal wear of crown
Measure: By Modified United States Public Health System criteria
Criteria:
Alpha: Occlusal surface intact
Bravo: Wear of occlusal surface without tooth surface exposure
Charlie: Wear of occlusal surface with exposure
Measure: By Modified United States Public Health System criteria
Criteria:
Alpha: Occlusal surface intact
Bravo: Wear of occlusal surface without tooth surface exposure
Charlie: Wear of occlusal surface with exposure
Measure: By Modified United States Public Health System criteria
Criteria:
Alpha: Occlusal surface intact
Bravo: Wear of occlusal surface without tooth surface exposure
Charlie: Wear of occlusal surface with exposure
Measured: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
retention
Measure: By Modified United States Public Health System criteria
Criteria:
Alpha: Intact
Bravo: Chipped/loss of material
Charlie: Complete loss of crown
Measured: Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Gingival Health
Measure: By Gingival Index
Scores:
0: Healthy gum
- Mild inflammation and edematous gingiva, no bleeding on probing
- Red edematous and shiny gingiva, bleeding on probing
- Red edematous and ulcerated gingiva, spontaneous bleeding
Measured: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Child and parental satisfaction
Measure: By 5-point Likert scale (Units of measurement)
- Very happy
- Happy
- Neither
- Unhappy
- Very unhappy Questionnaire Type: Ordinary or N/A (Existing validated tool)
Measured: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halah Mosaed Ali Alshaeri, Cairo University
- Investigators
- Hala m Alshaeri, Bachelor of Dental surgery, Principal investigator, Cairo university faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968767
- Sponsor's protocol ID
- PT-BFC VS ZRC
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
- ClinicalTrials.gov ID
- NCT06968767
- Acronym / sponsor ID
- PT-BFC VS ZRC
- Conditions
- Carious Primary Molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 13 May 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.
This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.
- Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.
- Secondary Objectives:
To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:
Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.
the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?
Detailed description
In pediatric dentistry, achieving efficient and aesthetic restoration of primary molars remains a significant challenge, particularly when treating young or anxious patients who may struggle with long or complex procedures. Zirconia crowns are widely used due to their durability, excellent biocompatibility, and natural tooth-like appearance, making them the gold standard for full-coverage aesthetic restorations in children. However, their placement involves extensive tooth preparation, which results in longer chair time and an increased risk of pulp exposure. These factors can negatively impact both treatment outcomes and patient behavior management.
Bioflex crowns have emerged as a potential alternative, offering a more flexible and user-friendly design that simplifies placement and reduces the amount of tooth preparation required. This may result in shorter procedure times and improved patient comfort. Despite these potential benefits, there is currently limited clinical evidence comparing the preparation time and efficiency of Bioflex crowns versus zirconia crowns for restoring primary molars.
This gap in knowledge makes it difficult for clinicians to make fully informed decisions about which crown system offers the best balance of procedural efficiency, aesthetics, and patient cooperation. By directly comparing Bioflex and zirconia crowns in terms of tooth preparation time and overall clinical practicality, the proposed study aims to determine whether Bioflex crowns provide a significant advantage in pediatric settings. The results could help identify the most time-efficient and effective restorative option for primary molars, ultimately improving care outcomes for pediatric patients.
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 crown | Experimental | Other: bioflx crown(Nu smile, united state) introduced Biofix Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Biofix Crowns are monochromatic, metal-free, tooth-colored crowns made up of high-strength resin polymer used in the medical device industry having high strength, flexibility, and durability. These crowns are autoclavable and are like SSC in tooth preparation as claimed by the manufacturer. Their flexibility and snap-fit technology aim to improve retention while minimizing trauma during placement. |
| group B performed zirconia crown | Experimental | Other: zirconia crownNuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation. NuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.
- Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
- Children whose parent or guardian is willing to sign an informed consent.
- Children whose parent or guardian are willing to comply with follow-up visits.
- Frankl's positive and definitely positive patient.
Key exclusion criteria (4 listed)
- Molars with severe structural loss that may compromise crown retention.
- Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
- Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.
- Children with any systemic conditions or disabilities that may affect their ability to participate in the study.
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 |
|---|---|---|
| bioflx crown(Group A: Preformed Biofix Crown - Assigned Intervention) Crown Selection \& Tooth Preparation: Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers. Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation: Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup: Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability. | Other | group A performed bioflx crown |
| zirconia crownGroup B: Preformed Zirconia Crown - Assigned Intervention) Crown Selection: Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts. Tooth Preparation: Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation in passively placed fissure bur. Crown Placement \& Passive Fit Check: Place the selected crown on the prepared tooth. Cementation of the Crown: Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating. | Other | group B performed zirconia crown |
Primary outcome
prepration time
Time frame: time frame: T0: 0 basline, follow up 12 month
measured by stop watch per minutes
4 secondary outcomes
Occlusal wear of crown
Time frame: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
retention
Time frame: Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Gingival Health
Time frame: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Child and parental satisfaction
Time frame: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
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 13 May 2025.
- Related InfoLink provided by the sponsor.
- 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.
halah M alshaeri, Bachelor of Dental surgery contact
Hala m Alshaeri, Bachelor of Dental surgery principal investigator
Cairo university faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bioflx crown and 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 5 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: opening soon, as of the sponsor's last update on 13 May 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 halah M alshaeri, Bachelor of Dental surgery (00201149038858 ext. 002, hala.mosaed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prepration time (time frame: time frame: T0: 0 basline, follow up 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.