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Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars

NCT07471360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-03-13

No results posted yet for this study

Summary

Informed consent was obtained from the parents/guardians of participating children after a detailed explanation about the treatment along with possible outcomes, risks, benefits, and discomforts is provided. In addition, assent forms were obtained from the participating children who are seven years and older. The inclusion criteria included children aged 6 to 9 years who were healthy, cooperative for dental treatment with rating of "definitely positive" or "positive" using Frankl Behavioral Rating Scale, and not known to be allergic to any components of the dental materials used in the study. Participants must have a minimum of one carious primary molar that requires a full-coverage restoration, as determined clinical and radiographical inclusion criteria for primary molars. The included primary molar should be fully erupted in occlusion and functional, have at least one proximal contact with an adjacent tooth, vital or requiring vital pulp therapy, show no clinical nor radiographic signs or symptoms of periradicular pathology, exhibit normal interproximal bone levels with no more than one-third root resorption radiographically. Children with severe malocclusion and/or periodontal disease were excluded as well as children requiring comprehensive dental treatment under general anesthesia.

The treatment was provided by two trained pediatric dentistry residents following the manufacturer's instructions and with an assistant's help, under the supervision of a consultant pediatric dentist. A new set of burs were used to prepare each crown. Appropriate pain management was delivered and the crowns were prepped according to manufacturer instructions and cemented.

The clinical evaluation was assessed during preparation, immediately after placement, at 3 month and 6 month follow-up appointments utilizing the Modified United States Public Health Services (USPHS) PYGE criteria for direct clinical evaluation of restorations.

Conditions

  • Dental Caries

Interventions

OTHER

Bioflx pediatric dental posterior crowns

Bioflx pediatric dental posterior crowns

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-01-30
Completion
2026-01-30

Countries

  • Saudi Arabia

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 NCT07471360 on ClinicalTrials.gov