Retention of Bioflx Crowns Compared to Zirconia Crowns on Primary Molars
ConditionCarious 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 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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
(Group A: Preformed Bioflx crown)
Other interventionprepartion: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 intervention1\. 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: (Group A: Preformed Bioflx crown)Experimental treatment 1 intervention
Group B: (Group B: Preformed zirconia crown)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Retention
Method of Measurement:Modified United States Public Health System criteria:Alpha: Intact Bravo:Chipped/loss of material Charlie: Complete loss of crown
Time frame
follow-up:T (Time): 6months interval T0: 0 T1: 3month T2: 6monthSecondary outcomes
1
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
Time frame
T (Time): 6months interval T0: 0 T1: 3 month T2: 6month2
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
T (Time): 6months interval T0: 0 T1: 3month T2: 6month3
child and parental satisfaction
Measure by: 5-Point likert's scale / Questionnaire:Ordinary or N/A
Time frame
T (Time): 6months interval T0: 0T1: 3month T2: 6month4
Preparation time
Measure by :Stopwatch per minutes.
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov
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