Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT06890949 | Not Yet Recruiting

• 1 other identifier: OW-BFC VS ZRC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the occlusal wear 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 occlusal wear of BioFlx crowns compared to 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,gingival health, preparation time, as well as child and parental satisfaction.

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• 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

  T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]

Secondary Outcomes (4)

• Retention

  [Time Frame: follow-up:T (Time): 12months interval T0: 0 T1: 3month T2: 6month T3 : 12 month]

• Gingival Health

  T (Time): 12 months interval T0: 0 T1: 3month T2: 6month T3 : 12 month]

• preparation time

  [Time Frame: baseline]

• child and parental satisfaction

  [Time Frame: T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]

Study Arms (2)

(Group A : preformed Bioflx crown

EXPERIMENTAL

Kids-e-Dental LLP (ANDHERI, MUMBAI, INDIA) introduced Bioflx Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Bioflx 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: (Group A: Preformed Bioflx Crown)

(Group B: Preformed 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 seeking a highly esthetic and long-lasting pediatric restoration

Other: (Group B: Preformed Zirconia crown)

Interventions

(Group A: Preformed Bioflx Crown) OTHER

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. Tooth Preparation 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 : preformed Bioflx crown

(Group B: Preformed Zirconia crown) OTHER

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 crown that closely matches the measured 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 using a tapered fissure bur. Crown Placement \& Passive Fit Check Place the selected crown and check for passive fit. 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 proper seating. Final Adjustments \& Cleanup Remove excess cement using floss or an explorer. Verify fit, occlusion, and stability

(Group B: Preformed 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 primary molar that needs to be covered by crown.
• Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
• 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. -
• 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 history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx 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 ,Giza, Egypt, 12613, Egypt

Location

Related Publications (1)

• Rahate I, Fulzele P, Thosar N. Comparative evaluation of clinical performance, child and parental satisfaction of Bioflx, zirconia and stainless steel crowns in pediatric patients. F1000Res. 2023 Dec 21;12:756. doi: 10.12688/f1000research.133464.2. eCollection 2023.

  PMID: 38911945 BACKGROUND

Study Officials

• Manal Ahmed Elshiekh, prof, PhD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Eithar musa Abdelrahman Hussion, Bachelor of dental science

CONTACT

00201098801323; Eithar.musa55@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 24, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): July 16, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)