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

Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars: 24-Month Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Other: Bioflx pediatric dental posterior crowns

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy children aged 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

How is the study designed?

Design Details

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

Number of Arms

1

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	The clinical assessment included the evaluation of oral hygiene and plaque index using the Greene and Vermillion index to evaluate oral hygiene and to score debris and dental plaque. After the patient rinsed with disclosing tablet, the discolored plaque was scored by running the side of an explorer over the buccal surface of teeth #16/55: #11/51: #26/65: and #31/71 and the lingual surface of teeth #36 or 75 and #46 or #85. While the gingival health will be evaluated using the gingival index (GI). The GI was measured using an explorer tip, gentle pressure within the sulcus of all the surfaces around each crown. The score will range from zero to three.The following parameters will assessed; the proximal contacts, resistance to dislodgment or crown fit before and after cementation, occlusion, crown staining, nature and wear of the opposing tooth, the marginal integrity using an explorer and a catch or a gap along all the margins, any changes in the surface of the crown, all in % .	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
child and parental satisfaction	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.	24 months

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Study record dates

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): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: satisfaction; pediatric dentistry; primary molars; BioFlx; full-coverage restoration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Behavior; Dental Caries; Personal Satisfaction
• 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