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

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.

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Key information

Conditions

Dental Caries Behavior Personal Satisfaction Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Abdulaziz University

Jeddah, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bioflx pediatric dental posterior crowns

Other

Bioflx pediatric dental posterior crowns

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 13, 2026
Registry last updated: Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed