Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:21 AM
Study NCT ID:
NCT07471360
Status:
COMPLETED
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars
Sponsor:
King Abdulaziz University
Organization:
Study Overview
Official Title:
Evaluation of Clinical and Radiographic Performance, and Parental and Children's Satisfaction of BioFlx Crowns in Primary Molars: 24-Month Follow-up
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: