NCT06847646

Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars

Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars (a Randomized Controlled Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 4 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled clinical trial is to to evaluate the clinical performance and radiographic success of BioFlex crowns versus SSCs using Hall Technique in primary dentition. The main questions it aims to answer are: Does bioflex crowns have the same clinical performance and radiographic success of stainless steel crowns when placed using Hall Technique? will bioflex crowns alter the occlusal vertical dimensions or affect the tempomandibular joint? If there is a comparison group: Researchers will compare bioflex crown to stainless steel crown to see of the bioflex crowns are effective as stainless steel crowns when placed using hall technique Participants will recieve bioflex crown and stainless steel crown according to randomization and they will be followed up immediately after treatment, after 2 weeks , after 1 months , after 3 months , after 6 months and after 12 months

Detailed description

The study will be a double-armed randomized controlled clinical trial, with parallel design. A total of 74 pediatric patients aged 4-8 years will be selected from the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Alexandria University, Egypt. Participants will be allocated into 2 groups according to the type of crown used. Group I (study group) will be treated with BioFlex crowns using Hall technique, while Group II (control group) will be treated with the SSCs using Hall technique. Clinical and radiographic success of both crowns will be assessed. The function of the temporomandibular joint (TMJ) will be evaluated using the Helkimo Clinical Dysfunction Index (Di) and the AAPD questionnaire. The Occlusovertical dimension measurements will also be evaluated using the Van der Zee and Van Amerongen method. Plaque and gingival health will be recorded using plaque and gingival indices, and the satisfaction level of the child will be assessed using the Facial Image Scale (FIS), while the satisfaction level of parents will be assessed using questionnaire.

Conditions

• BioFlex Crowns Using Hall Technique

Interventions

Type	Name	Description
OTHER	bioflex crown using hall technique	crowns assessment
OTHER	stainless steel crown using hall technique	crown assessment

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-08-20
• Completion: 2025-08-20
• First posted: 2025-02-26
• Last updated: 2025-12-18

Locations

1 site across 1 country: Egypt