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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-8
SponsorCairo University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • (Group A: Bioflx crowns)

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: (Group A: Performed Bioflx crowns)Experimental treatment 1 intervention
Group B: (Group B: Preformed zirconia crown)Experimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

1

Retention

Measure by Modified United States Public Health System criteria: Alpha: Intact. Bravo:Chipped/loss of material. Charlie: Complete loss of crown.

Time frame
[Time Frame: follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
2

Occlusal wear of crown

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 exposure.

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

Gingival health

Measure by: Gingival index: 0: healthy gum. 1. mild discoloration and edematous gingiva no bleeding on probing. 2. red oedematous and shiny gingiva bleeding on probing. 3. red oedematous and ulceration gingiva spontaneous bleeding.

Time frame
[Time Frame: T (Time): 6months interval T0: 0 T1: 3month T2: 6month]
4

Preparation time

Measure by :Stopwatch per minutes.

Time frame
[Time Frame: baseline]

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Dentistry, Cairo University. Status unavailable 12613, Giza, Cairo GovernorateEgyptEgypt

Sponsors and contacts

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