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ACTIVE NOT RECRUITING
NCT07691905
NA

Zirconia and Bioflx Crowns for Primary Anterior Teeth

Sponsor: Hue University of Medicine and Pharmacy

View on ClinicalTrials.gov

Summary

This parallel-group randomized controlled trial will compare the clinical performance of prefabricated zirconia and Bioflx crowns for restoring primary maxillary anterior teeth in children aged 3 to 5 years. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a zirconia crown or a Bioflx crown. Clinical outcomes will be assessed at 3, 6, and 12 months after crown placement. Evaluations will include gingival health, plaque accumulation, wear of the opposing tooth, crown retention, and clinical symptoms of the treated tooth. Parent satisfaction with the esthetic outcome will also be evaluated. The study aims to provide comparative clinical evidence on the effectiveness of zirconia and Bioflx crowns for restoration of primary maxillary anterior teeth.

Official title: Clinical Outcomes of Prefabricated Zirconia and Bioflx Crowns for Restoring Primary Maxillary Anterior Teeth: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

3 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-01-04

Completion Date

2027-04

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

OTHER

Zirconia Crown

Prefabricated zirconia crowns manufactured by Shinhung, Republic of Korea, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol.

OTHER

Bioflx Crown

Prefabricated Bioflx crowns manufactured by Kids-e-Dental, India, will be used to restore eligible primary maxillary anterior teeth. Tooth preparation, crown selection, cementation with Fuji IX Extra glass ionomer cement, removal of excess cement, and post-treatment instructions will follow a standardized protocol.

Locations (1)

Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University

Huế, Vietnam