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

NCT06968767 | Not Yet Recruiting

• 1 other identifier: PT-BFC VS ZRC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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?

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• prepration time

  measured by stop watch per minutes

  time frame: T0: 0 basline, follow up 12 month

Secondary Outcomes (4)

• Occlusal wear of crown

  T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months

• retention

  Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months

• Gingival Health

  12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months

• Child and parental satisfaction

  T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months

Study Arms (2)

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.

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.

Other: zirconia crown

Interventions

bioflx crown 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 A performed bioflx crown

zirconia crown 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.

group B performed zirconia crown

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Egypt, 12613, Egypt

Location

Related Links

• Related Info

Study Officials

• Hala m Alshaeri, Bachelor of Dental surgery

  Cairo university faculty of dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

halah M alshaeri, Bachelor of Dental surgery

CONTACT

00201149038858; hala.mosaed@dentistry.cu.edu.eg

Manal A Elshiekh, prof, phd

CONTACT

0223642705; rec@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: June 15, 2025
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 16, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)