Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06856070

Retention of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University., Cairo, Giza Governorate, Egypt

Loading trial locations.

About this study

Primary molars play a significant role in maintaining oral function, esthetics, and space for permanent teeth, therefore, restoring decayed primary molars is a critical aspect of pediatric dentistry. Stainless steel crowns have been the standard restorative material for primary molars due to their clinical success, retention, and durability. However, the aesthetic limitations of SSCs, have been problematic, especially when patients seek more esthetically acceptable treatment options.In an attempt to address the aesthetic limitations of stainless-steel crowns, pre-veneered stainless-steel crowns were introduced featuring a thin layer of composite resin or ceramic on the outside to improve their appearance. While they provided a better aesthetic than pure stainless steel, their limitations included a tendency to wear down over time, difficulty in matching natural tooth color, and the potential for the veneer to chip or detach.Recently, zirconia crowns are preferred over pre-veneered stainless-steel crowns for their esthetic superiority, biocompatibility, and resistance to wear. They demonstrate excellent retention and durability but require significant tooth preparation, which may compromise tooth structure. Despite their advantages, zirconia crowns posed challenges such as increased cost, more complex preparation techniques, and concerns about their brittleness under certain conditions. Moreover, zirconia crowns may not be suitable for all cases, especially those involving less mineralized or structurally compromised primary molars .In 2021, Kids-e-Dental LLP 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.

It is important to mention that retention is a crucial factor for the success of any dental crown. An inadequate retention can lead to crown displacement, necessitating re-treatment, and ultimately affect the long-term health of the primary tooth. While studies have demonstrated the superior esthetic properties of materials like Bioflx crowns, their clinical performance, particularly retention rates and overall longevity, require further evaluation in direct comparison to zirconia crowns .Thus, this trial aims to fill the gap in current knowledge and provide clinicians with evidence to support the choice of crown material based on retention performance, which is critical to the long-term success of pediatric restorations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The inclusion criteria:

  • 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. -

Exclusion criteria

  • The exclusion criteria
  • 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.

Treatment and study plan

(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.

  • 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)

Other
  • 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.

Primary outcomes

  1. Retention

    Time frame: 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

Secondary outcomes

  1. Occlusal wear of crown

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

    Measure by Modified United States Public Health System criteria:

    Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with

  2. Gingival health

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

    Measure by: Gingival index:

    0: healthy gum

    • mild discoloration and edematous gingiva no bleeding on probing
    • red oedematous and shiny gingiva bleeding on probing
    • red oedematous and ulceration gingiva spontaneous bleeding
  3. child and parental satisfaction

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

    Measure by: 5-Point likert's scale / Questionnaire:Ordinary or N/A

  4. Preparation time

    Time frame: baseline

    Measure by :Stopwatch per minutes.

Study contacts

Contact information is provided by the study sponsor or research team.

noura jamal elnoor mohamed, bachelor of dental science

CONTACT

[email protected]

00201148788374

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Retention and Resistance to Dislodgement of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 4, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.