Clinical Performance and Immediate Child and Parental Satis-faction With BioFlx Crowns in Primary Molars: A Prospective, Single-Arm, Non-Randomized Interventional Study

August 30, 2026 updated by: Shahad Abudawood, King Abdulaziz University
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. Healthy children or children with mild, stable systemic medical conditions, who were cooperative and required at least one full-coverage restoration in a primary molar were recruited from the pe-diatric dentistry clinics at King Abdulaziz University Faculty of Dentistry. BioFlx crowns were placed by trained pediatric dentistry residents under a consultant's supervision. Immediately after crown cementation, proximal contact and occlusion were recorded. At three- and six-month fol-low-up visits, clinical outcomes evaluated were the proximal contacts, occlusion, crown retention, staining, wear of the opposing tooth, marginal integrity, and any changes in the crown material surface. In addition, plaque accumulation and gingival health around each crowned tooth were assessed at the tooth level. Immediate post-treatment satisfaction of children and their parents was assessed following crown cementation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy children or with mild stable systemic medical condition such as controlled asthma, Age 6 to 9 years
  • Cooperative
  • One primary molar that requires a full-coverage restoration with at least one proximal contact with the adjacent tooth
  • No clinical or radiographic signs or symptoms of periradicular pathology
  • Normal interproximal bone levels
  • No more than one-third root resorption radiographically

Exclusion Criteria:

  • Children with severe malocclusion
  • Children with periodontal disease
  • Children requiring comprehensive dental treatment under general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BioFlx crowns
Other: Bioflx pediatric dental posterior crowns
Bioflx pediatric dental posterior crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 6 months

Before preparation, participant-level baseline data were recorded, including dental history and a comprehensive preoperative full-mouth oral health assessment comprising dental caries experience recorded using the dmft/DMFT indices, oral hygiene using the Greene and Vermillion Simplified Oral Hygiene Index (OHI-S), and gingival health assessed using the Löe and Silness Gingival Index.

Furthermore, the clinical assessment comprised multiple parameters, including selected criteria adapted from the modified United States Public Health Service (USPHS) system for the direct clinical evaluation of restorations [16], namely marginal integrity and crown staining; crown-specific clinical criteria adapted from Donly et al., namely proximal contact, occlusion, crown retention, and wear of the opposing tooth; established plaque accumulation and bleeding on probing and a study-specific criterion for evaluating the surface integrity of BioFlx crowns.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
child and parental satisfaction
Time Frame: immediate post treatment
Child and parental satisfaction survey.The questionnaire encompass an individual interview with the children and their parents/guardians in a separate setting. The participants were asked to indicate their satisfaction with the crown color, shape, size, and overall appearance on a Likert's scale from one to ten, in which one indicates very satisfied/very acceptable and ten indicates not satisfied at all/ not acceptable at all.
immediate post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53-03-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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