Zirconia and Bioflx Crowns for Primary Anterior Teeth

NCT07691905 | Active Not Recruiting

• 1 other identifier: H2025/387
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Tooth Hypomineralization; Dental Caries

Keywords

Primary Maxillary Anterior Teeth; Zirconia Crowns; Bioflx Crowns

Outcome Measures

Primary Outcomes (5)

• Gingival index

  Gingival status adjacent to crowned primary maxillary anterior teeth, assessed using the Löe and Silness Gingival Index. Lower scores indicate better gingival health.

  3, 6, and 12 months after crown placement

• Fluorescent Plaque Index

  Plaque accumulation on crowned primary maxillary anterior teeth, assessed using QrayScan Plus according to the Fluorescent Plaque Index (FPI; 0-5). Higher scores indicate greater plaque accumulation.

  3, 6, and 12 months after crown placement

• Opposing Tooth Wear

  Wear of the tooth opposing the crowned primary maxillary anterior tooth, assessed clinically on a 0-4 ordinal scale. Higher scores indicate greater enamel and dentin loss.

  3, 6, and 12 months after crown placement

• Crown Retention

  Retention status of the prefabricated crown, categorized as retained or loose/lost.

  3, 6, and 12 months after crown placement

• Clinical Status of Crowned Teeth

  Clinical status of teeth restored with prefabricated crowns, categorized as asymptomatic, sensitive, mobile, painful, or swollen.

  3, 6, and 12 months after crown placement

Secondary Outcomes (1)

• Parental Satisfaction

  6 and 12 months after crown placement

Study Arms (2)

Zirconia

ACTIVE COMPARATOR

Participants receive prefabricated zirconia crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement.

Other: Zirconia Crown

Bioflx

EXPERIMENTAL

Participants receive prefabricated Bioflx crowns for restoration of indicated primary maxillary anterior teeth. Teeth are prepared using a standardized clinical protocol, and crowns are cemented with Fuji IX Extra glass ionomer cement.

Other: Bioflx Crown

Interventions

Zirconia Crown OTHER

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.

Zirconia

Bioflx Crown OTHER

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.

Bioflx

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 5 years.
• Children requiring full-coverage restoration of one or more primary maxillary anterior teeth.
• Presence of an opposing tooth.
• Target tooth with at least two carious surfaces, caries involving the incisal edge, or discoloration associated with hypomineralization.
• Written informed consent from a parent or legal guardian and willingness to comply with treatment and follow-up visits.

You may not qualify if:

• Allergy to Fuji IX Extra glass ionomer cement.
• Acute systemic disease.
• Crowded teeth affecting crown placement.
• Pulp exposure before treatment.
• Inadequate remaining clinical crown structure after tooth preparation.
• Absence of an opposing tooth.
• Bruxism or deep bite.
• Tooth close to exfoliation or root resorption exceeding one-half of the root length.
• Caries limited to a single surface without proximal involvement.
• History of trauma affecting the target tooth.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

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

Huế, 530000, Vietnam

Location

Related Publications (1)

• Gill A, Garcia M, Won An S, Scott J, Seminario AL. Clinical Comparison of Three Esthetic Full-Coverage Restorations in Primary Maxillary Incisors at 12 Months. Pediatr Dent. 2020 Sep 15;42(5):367-372.

  PMID: 33087221 RESULT

MeSH Terms

Conditions

Dental Caries; Dental Enamel Hypomineralization

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: January 4, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)