Child and Parental Satisfaction of Bioflx Crowns Compared to Zirconia Crowns in Primary Molars

NCT06897020 | Not Yet Recruiting

• 1 other identifier: CPS - Bioflx Vs ZR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carious Primary Molars

Outcome Measures

Primary Outcomes (1)

• Child and Parents Satisfaction

  Method of Measurement: * 5-Point likert's scale unites of measurement: 1. Very Happy. 2. Happy. 3. Neither. 4. Unhappy. 5. Very Unhappy. * Questionnaire:Ordinary or N/A existing validated tool.

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

Secondary Outcomes (4)

• Retention

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

• Occlusal wear of crown

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

• Gingival health

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

• Preparation time

  [Time Frame: baseline]

Study Arms (2)

(Group A: Performed Bioflx crowns)

EXPERIMENTAL

Bioflx Crowns, claimed to be the first flexible, durable, and aesthetic preformed crowns for primary molars. Bioflx are monochromatic, metal-free, tooth-colored crowns made from a high-strength resin polymer used in the medical device industry, offering strength, flexibility, and durability.These crowns are autoclavable and are claimed to require similar tooth preparation as SSCs.

Other: (Group A: Bioflx crowns)

(Group B: Preformed zirconia crown)

EXPERIMENTAL

Zirconia crowns brought a concept shift in esthetics of crowns; they are the most esthetic option available for treating primary molars. These crowns are resilient, tooth-colored, and highly polished. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority.

Other: (Group B: Preformed Zirconia crown

Interventions

(Group A: Bioflx crowns) 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: Performed Bioflx crowns)

(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: 1mm of interproximal reduction will be performed using a flame-shaped diamond bur such as a .368 or .330tapered 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 four to eight years old who are appearing healthy and free of any systemic disease according to parental history.
• Frankl's positive and definitely positive children.
• 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:

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• Children with
• 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.
• Child with parafunctional habits.
• Molars with severe structural loss that may compromise crown retention.
• Presence of malocclusion such as crossbite or scissor bite.
• Primary molar with root caries.
• Primary molar with root resorption or furcation involvement.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University.

Giza, Cairo Governorate, 12613, Egypt

Location

Related Publications (2)

• Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.

  PMID: 32509626 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

• Prof.Dr. Manal Ahmed Elshiekh, Ph.D

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Razan Adil Yousif Ahmed, Bachelor of dental science

CONTACT

00201010118444; Razanadil.14@gmail.com

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: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: February 26, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)