Evaluation Of Preparation Time Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- prepration time
Study Overview
Brief Summary
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?
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged between 4 and 8 years with a primary molar that needs to be covered by a crown.
- •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
- •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 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.
Arms & Interventions
group A performed bioflx crown
(Nu smile, united state) introduced Biofix Crowns and claimed as the first flexible, durable, and esthetic preformed crown for primary molars. Biofix 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.
Intervention: bioflx crown (Other)
group B performed zirconia crown
NuSmile Zirconia Crowns are prefabricated, esthetic full-coverage restorations designed for primary teeth. Known for their superior strength, durability, and natural tooth-like appearance, these crowns provide an excellent alternative to traditional stainless steel crowns. Made from high-quality medical-grade zirconia, they are biocompatible, resistant to chipping, and highly polished to minimize plaque accumulation and gingival irritation.
NuSmile Zirconia Crowns require significant tooth preparation for proper fit and retention. They are available in various sizes to accommodate different primary molars and anterior teeth. Their lifelike translucency and color-matching capabilities make them a preferred choice for parents and clinicians.
Intervention: zirconia crown (Other)
Outcomes
Primary Outcomes
prepration time
Time Frame: time frame: T0: 0 basline, follow up 12 month
measured by stop watch per minutes
Secondary Outcomes
- Occlusal wear of crown(T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months)
- retention(Follow-up: 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months)
- Gingival Health(12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months)
- Child and parental satisfaction(T (Time): 12 months Intervals: T0: 0, T1: 3 months, T2: 6 months, T3: 12 months)
Investigators
Halah Mosaed Ali Alshaeri
principle investigator
Cairo University