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

NCT06897020 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2025-06-01

Last updated

2025-03-28

Condition(s) studied

Carious Primary Molars

Investigational drug(s) / intervention(s)

(Group A: Bioflx crowns)(Group B: Preformed Zirconia crown

(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 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 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 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.

Study 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.

Eligibility

Sex

ALL

Min age

4 Years

Max age

8 Years

Healthy volunteers

Accepted

Inclusion Criteria: * The Inclusion criteria: 1. Children aged four to eight years old who are appearing healthy and free of any systemic disease according to parental history. 2. Frankl's positive and definitely positive children. 3. Children whose parent or guardian are willing to sign an informed consent. 4. Children whose parent or guardian are willing to comply with follow-up visits. 5. Primary molars indicated for crowns. • Exclusion criteria:  1. Children with Exclusion Criteria: * The Exclusion criteria: 1. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations. 2. Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns. 3. Child with parafunctional habits. 4. Molars with severe structural loss that may compromise crown retention. 5. Presence of malocclusion such as crossbite or scissor bite. 6. Primary molar with root caries. 7. Primary molar with root resorption or furcation involvement.

Primary outcome measure(s)

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

Trial sites (1)

Facility	City	Region	Status
Faculty of Dentistry, Cairo University.	Giza	Cairo Governorate

More Cairo University trials in Egypt

Neuromuscular Inhibition Technique on Iliotibial Band Friction Syndrome Active, not recruiting

Biomechanical Risk Factors of Cervical Pain in Pregnant Women Starting soon

Prevalence of MIH in Young Adults At Cairo University Dental Hospital and Its Link to Dental Cavities: a Cross-Sectional Study Starting soon

Comparison of ZOE vs ZON in Primary Mandibular Molars Pulpectomy of 5-7-Year-Olds Starting soon

Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay Starting soon

Other trials for the same condition

Comparison of ZOE vs ZON in Primary Mandibular Molars Pulpectomy of 5-7-Year-Olds Starting soon

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

Pain Perception of Novel Chemo-mechanical Caries Remove Versus Atraumatic Restorative Treatment Method in Primary Molars Starting soon

Retention of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars Starting soon

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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06897020 on ClinicalTrials.gov ↗ ← All trials in Egypt