Retention of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars

NCT06856070 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2025-06-30

Last updated

2025-03-04

Condition(s) studied

Carious Primary Molars

Investigational drug(s) / intervention(s)

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

(Group A: Preformed Bioflx crown): 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: 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.

Study 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.

Eligibility

Sex

ALL

Min age

4 Years

Max age

8 Years

Healthy volunteers

Accepted

Inclusion Criteria:The inclusion criteria: 1. Children aged between 4 and 8 years with primary molar that needs to be covered by crown. 2. Children who can cooperate sufficiently for the duration of the procedure, as assessed by behavior management techniques. 3. Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification). 4. Children whose parent or guardian are willing to sign an informed consent. 5. Children whose parent or guardian are willing to comply with follow-up visits. - Exclusion Criteria: * The exclusion criteria 1. Molars with severe structural loss that may compromise crown retention. 2. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations. 3. Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns. 4. Children with any systemic conditions or disabilities that may affect their ability to participate in the study.

Primary outcome measure(s)

Retention — follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month
Method of Measurement:Modified United States Public Health System criteria:Alpha: Intact Bravo:Chipped/loss of material Charlie: Complete loss of crown

Trial sites (2)

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

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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 NCT06856070 on ClinicalTrials.gov ↗ ← All trials in Egypt