Faculty of Dentistry Cairo University
Cairo, Egypt, 12613
Location contact
faculty of dentistry cairo university
CONTACT
hala mosaed ali alshaeri, bachelore of dental science
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06968767
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?
Trial opening soon.
Get Notified4 year–8 year
All sexes
Interventional
Not applicable
Cairo, Egypt, 12613
faculty of dentistry cairo university
CONTACT
hala mosaed ali alshaeri, bachelore of dental science
PRINCIPAL_INVESTIGATOR
In pediatric dentistry, achieving efficient and aesthetic restoration of primary molars remains a significant challenge, particularly when treating young or anxious patients who may struggle with long or complex procedures. Zirconia crowns are widely used due to their durability, excellent biocompatibility, and natural tooth-like appearance, making them the gold standard for full-coverage aesthetic restorations in children. However, their placement involves extensive tooth preparation, which results in longer chair time and an increased risk of pulp exposure. These factors can negatively impact both treatment outcomes and patient behavior management.
Bioflex crowns have emerged as a potential alternative, offering a more flexible and user-friendly design that simplifies placement and reduces the amount of tooth preparation required. This may result in shorter procedure times and improved patient comfort. Despite these potential benefits, there is currently limited clinical evidence comparing the preparation time and efficiency of Bioflex crowns versus zirconia crowns for restoring primary molars.
This gap in knowledge makes it difficult for clinicians to make fully informed decisions about which crown system offers the best balance of procedural efficiency, aesthetics, and patient cooperation. By directly comparing Bioflex and zirconia crowns in terms of tooth preparation time and overall clinical practicality, the proposed study aims to determine whether Bioflex crowns provide a significant advantage in pediatric settings. The results could help identify the most time-efficient and effective restorative option for primary molars, ultimately improving care outcomes for pediatric patients.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification).
Children whose parent or guardian is willing to sign an informed consent.
Children whose parent or guardian are willing to comply with follow-up visits.
Frankl's positive and definitely positive patient.
Exclusion criteria
Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations.
Children with a history of allergies; known allergies to dental local anesthesia or to the materials used in Biofix crowns.
Children with any systemic conditions or disabilities that may affect their ability to participate in the study.
(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.
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.
Time frame: time frame: T0: 0 basline, follow up 12 month
measured by stop watch per minutes
Time frame: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
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: Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Measure: By Modified United States Public Health System criteria
Criteria:
Alpha: Intact
Bravo: Chipped/loss of material
Charlie: Complete loss of crown
Time frame: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Measure: By Gingival Index
Scores:
0: Healthy gum
Time frame: T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months
Measure: By 5-point Likert scale (Units of measurement)
Contact information is provided by the study sponsor or research team.
Manal A Elshiekh, prof, phd
CONTACT
0223642705 ext. 002
halah M alshaeri, Bachelor of Dental surgery
CONTACT
00201149038858 ext. 002
Cairo University
Other
Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
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.
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