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Zirconia and Bioflx Crowns for Primary Anterior Teeth

NCT07691905 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-09

No results posted yet for this study

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.

Conditions

  • Dental Caries
  • Tooth Hypomineralization

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.

Sponsors & Collaborators

  • Hue University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-04
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07691905 on ClinicalTrials.gov