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

Official title

Evaluation Of Child and Parental Satisfaction Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

Overview

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.

Detailed description

The management of severely decayed primary teeth in pediatric dentistry often requires the use of crowns to restore function and aesthetics. Traditional stainless-steel crowns (SSCs) have been widely used due to their durability and cost-effectiveness; however, their metallic appearance and lack of aesthetic appeal have prompted the development of alternative materials such as zirconia and Bioflx crown. Zirconia crowns are recognized for their superior aesthetics and biocompatibility, making them a preferred choice for parents who prioritize appearance. However, they can present challenges in terms of retention, preparation requirements, and cost. Bioflx crowns, a newer material in pediatric dentistry, aim to combine aesthetic appeal with flexibility and improved adaptability to tooth anatomy. Despite their growing popularity, limited research directly compares the child and parental satisfaction between zirconia and Bioflx crowns. It remains unclear which material offers the best balance of functional, aesthetic, and patient-centered outcomes.This gap in knowledge hinders evidence-based decision-making when selecting crowns for pediatric patients. Zirconia crowns have gained prominence in pediatric dentistry as an alternative to stainless steel crowns for primary molars. While SSCs have long been valued for their durability and ease of placement, their metallic appearance often presents an aesthetic concern for parents and patients. Zirconia crowns provide a more natural, tooth-colored alternative, making them a preferred option in cases where aesthetics is a priority. One of the main advantages of zirconia crowns is their biocompatibility, as they demonstrate lower plaque accumulation and gingival inflammation. Additionally, zirconia crowns offer superior mechanical properties, including high flexural strength and excellent fracture resistance, making them a long-lasting restorative option. Their wear resistance further supports their use in pediatric patients, particularly those with heavy occlusal forces. This study stems from the need to bridge the gap in current research regarding the satisfaction and the effectiveness associated with Bioflx crowns. Understanding whether Bioflx crowns offer superior aesthetic and functional outcomes compared to Zirconia crowns could influence clinical decision-making in pediatric dentistry. This is especially relevant as parents increasingly seek restorations that provide both durability and a natural appearance for their children.

Interventions

• Other (Group A: Bioflx crowns)
  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
• Other (Group B: Preformed Zirconia crown
  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 pe

Primary outcome measures

• Child and Parents Satisfaction [Time frame: [Time Frame: T (Time): 6months interval T0: 0T1: 3month T2: 6month]]

Secondary outcome measures (4)

• Retention [Time frame: [Time Frame: follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month]]
• Occlusal wear of crown [Time frame: [Time Frame: T (Time): 6months interval T0: 0 T1: 3 month T2: 6month]]
• Gingival health [Time frame: [Time Frame: T (Time): 6months interval T0: 0 T1: 3month T2: 6month]]
• Preparation time [Time frame: [Time Frame: baseline]]

Eligibility criteria

Inclusion criteria

• The Inclusion criteria:

• 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.
• Primary molars indicated for crowns. • Exclusion criteria:

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• Children with

Exclusion criteria

• The Exclusion criteria:

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry, Cairo University. — Giza

Publications

• 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
• 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

Identifiers

NCT: NCT06897020 · CPS - Bioflx Vs ZR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗