Retention of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars

NCT06856070 | Not Yet Recruiting

• 1 other identifier: RR-BFC Vs ZR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to evaluate the retention and resistance to dislodgment 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 retention and resistance to dislodgement 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 occlusal wear, gingival health, preparation time, as well as child and parental satisfaction.

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• Retention

  Method of Measurement:Modified United States Public Health System criteria:Alpha: Intact Bravo:Chipped/loss of material Charlie: Complete loss of crown

  follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month

Secondary Outcomes (4)

• Occlusal wear of crown

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

• Gingival health

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

• child and parental satisfaction

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

• Preparation time

  baseline

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

Zirconia crowns have been widely used in pediatric dentistry due to their high esthetic value, biocompatibility, and strength. Studies have shown that zirconia crowns exhibit superior retention due to their passive fit and resistance to fracture.

Other: (Group B: Preformed Zirconia crown)

Interventions

(Group A: Preformed Bioflx crown) 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 A: Preformed Bioflx crown)

(Group B: Preformed Zirconia crown) OTHER

1\. 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: 1 mm of interproximal reduction will be performed using a flame-shaped diamond bur such as a .368 or .330 tapered 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.

(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.
• Children who can cooperate sufficiently for the duration of the procedure, as assessed by behavior management techniques.
• 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. -

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 (2)

Faculty of Dentistry, Cairo University.

Cairo, Giza Governorate, 12613, Egypt

Location

Faculty of Dentistry, Cairo University.

Cairo, Egypt

Location

Related Publications (2)

• 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

• Patil 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.

  PMID: 38616425 BACKGROUND

Study Officials

• Dr.manal ahmed elshiekh Prof, Ph.D

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

noura jamal elnoor mohamed, bachelor of dental science

CONTACT

00201148788374; nourajamal997@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: February 25, 2025
• First Posted: March 4, 2025
• Study Start: June 30, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)