Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT ID: NCT06968767

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2026-06-16

Brief 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.

• 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.

Conditions

Carious Primary Molars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

group A performed 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 Type: EXPERIMENTAL

bioflx crown

Intervention Type: OTHER

(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.

group B performed zirconia crown

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.

Group Type: EXPERIMENTAL

zirconia crown

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

zirconia crown

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Halah Mosaed Ali Alshaeri

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala m Alshaeri, Bachelor of Dental surgery

Role: PRINCIPAL_INVESTIGATOR

Cairo university faculty of dentistry

Locations

Faculty of Dentistry Cairo University

Cairo, Egypt, Egypt

Countries

Egypt

Central Contacts

halah M alshaeri, Bachelor of Dental surgery

Role: CONTACT

hala.mosaed@dentistry.cu.edu.eg

00201149038858 ext. 002

Manal A Elshiekh, prof, phd

Role: CONTACT

rec@dentistry.cu.edu.eg

0223642705 ext. 002

Facility Contacts

faculty of dentistry cairo university

Role: primary

rec@dentistry.cu.edu.eg

0020223642705

Related Links

https://pubmed.ncbi.nlm.nih.gov/38911945/

Related Info

Other Identifiers

PT-BFC VS ZRC

Identifier Type: -

Identifier Source: org_study_id