Health TrialsbyHealthPanel

Preparation Time 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

This study aims to evaluate and compare the preparation time required for Bioflx crowns versus zirconia crowns on primary molars through a randomized clinical trial.

• Primary Objective: To compare the preparation time required for Bioflex crowns and zirconia crowns on primary molars in pediatric patients.

• Secondary Objectives:

To evaluate the clinical performance of Bioflex crowns compared to zirconia crowns, including:

Retention, Patient Satisfaction, Parental Satisfaction, Occlusal Wear and Gingival Health.

the main question it aim to answer: Is there a significant difference in the preparation time required for Bioflx crowns compared to zirconia crowns in the primary molars of pediatric patients?

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.

Disqualifiers

Molars with severe structural loss that may compromise crown retention.

Trial design

Design model

Parallel

Treatments tested in this trial

  • bioflx crown

    Other intervention

    (Group A: Preformed Biofix Crown - Assigned Intervention) Crown Selection \& Tooth Preparation: Measure the mesiodistal width using calipers to select an appropriately sized crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the crown that closely matches the measured mesiodistal width. Select the smallest crown that preserves proximal contacts using a trial-and-error approach. If crimping is necessary, use Howe's pliers. Perform 1-1.5 mm occlusal reduction using a tapered diamond bur. Reduce proximal areas by approximately 0.5 mm to clear the contact area. Crown Placement \& Cementation: Ensure a snug fit of the selected crown. Apply a thin layer of glass ionomer cement inside the crown. Seat the crown firmly using finger pressure. Have the child bite down gently to ensure proper seating. Final Adjustments \& Cleanup: Remove excess cement with floss or an explorer. Verify the crown's fit, occlusion, and stability.

  • zirconia crown

    Other intervention

    Group B: Preformed Zirconia Crown - Assigned Intervention) Crown Selection: Measure the mesiodistal width using calipers to select the appropriate crown. If a mesial or distal wall is missing, use the contralateral tooth for size selection. Choose the one that closely matches the mesiodistal width. Select the smallest crown that preserves proximal contacts. Tooth Preparation: Reduce the occlusal surface by 1.5-2 mm using a tapered diamond bur. Reduce interproximal areas by 1-1.5 mm, ensuring a feather-edge finish. Perform a 1-2 mm subgingival preparation in passively placed fissure bur. Crown Placement \& Passive Fit Check: Place the selected crown on the prepared tooth. Cementation of the Crown: Apply a thin layer of glass ionomer cement inside the crown. Seat the crown with passive finger pressure. Have the child bite down gently to ensure seating.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: group A performed bioflx crownExperimental treatment 1 intervention
Group B: group B performed zirconia crownExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

prepration time

measured by stop watch per minutes

Time frame
time frame: T0: 0 basline, follow up 12 month

Secondary outcomes

1

Occlusal wear of crown

Measure: By Modified United States Public Health System criteria Criteria: Alpha: Occlusal surface intact Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with exposure Measure: By Modified United States Public Health System criteria Criteria: Alpha: Occlusal surface intact Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with exposure Measure: By Modified United States Public Health System criteria Criteria: Alpha: Occlusal surface intact Bravo: Wear of occlusal surface without tooth surface exposure Charlie: Wear of occlusal surface with exposure

Time frame
T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
2

retention

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

Time frame
Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
3

Gingival Health

Measure: By Gingival Index Scores: 0: Healthy gum 1. Mild inflammation and edematous gingiva, no bleeding on probing 2. Red edematous and shiny gingiva, bleeding on probing 3. Red edematous and ulcerated gingiva, spontaneous bleeding

Time frame
12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
4

Child and parental satisfaction

Measure: By 5-point Likert scale (Units of measurement) 1. Very happy 2. Happy 3. Neither 4. Unhappy 5. Very unhappy Questionnaire Type: Ordinary or N/A (Existing validated tool)

Time frame
T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: