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

NCT07471360 | Completed

• 1 other identifier: 53-03-24
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dental Caries

Keywords

pediatric dentistry; satisfaction; primary molars; BioFlx; full-coverage restoration

Outcome Measures

Primary Outcomes (1)

• Clinical performance

  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 Outcomes (1)

• child and parental satisfaction

  immediate post treatment

Study Arms (1)

BioFlx crowns

EXPERIMENTAL

BioFlx crowns

Other: Bioflx pediatric dental posterior crowns

Interventions

Bioflx pediatric dental posterior crowns OTHER

Bioflx pediatric dental posterior crowns

BioFlx crowns

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries; Personal Satisfaction

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: December 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)