Occlusal Wear Of Bioflx Crowns Compared To Zirconia Crowns On Primary Molars

NCT06890949 · tracked via the Priya Life Science Egypt tracker

Sponsor

Cairo University

Phase

Not applicable

Started

2025-06-15

Last updated

2025-03-24

Condition(s) studied

Carious Primary Molars

Investigational drug(s) / intervention(s)

(Group A: Preformed Bioflx Crown)(Group B: Preformed Zirconia crown)

(Group A: Preformed Bioflx Crown): 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. Tooth Preparation 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): 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 crown that closely matches the measured 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 using a tapered fissure bur. Crown Placement \& Passive Fit Check Place the selected crown and check for passive fit. 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 proper seating. Final Adjustments \& Cleanup Remove excess cement using floss or an explorer. Verify fit, occlusion, and stability

Study summary

The goal of this clinical trial is to evaluate the occlusal wear 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 occlusal wear 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 retention,gingival health, preparation time, as well as child and parental satisfaction.

Eligibility

Sex

ALL

Min age

4 Years

Max age

8 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Children aged between 4 and 8 years with primary molar that needs to be covered by crown. 2. Medically healthy children (ASA I or II according to the American Society of Anesthesiologists classification). 3. Children whose parent or guardian are willing to sign an informed consent. 4. Children whose parent or guardian are willing to comply with follow-up visits. - 5. Frankl's positive and definitely positive patient Exclusion Criteria: 1. Molars with severe structural loss that may compromise crown retention. 2. Children with poor oral hygiene that may contribute to higher plaque levels and affect the clinical outcomes of the crown restorations. 3. Children with history of allergies; Known allergies to dental local anesthesia or to the materials used in Bioflx crowns. 4. Children with any systemic conditions or disabilities that may affect their ability to participate in the study.

Primary outcome measure(s)

Occlusal wear of crown — T (Time): 12months interval T0: 0 T1: 3 month T2: 6month T3: 12 month]
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

Trial sites (1)

Facility	City	Region	Status
Faculty of dentistry cairo university	Cairo ,Giza	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06890949 on ClinicalTrials.gov ↗ ← All trials in Egypt