Clinical trial NCT06973616: A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars
Official title: A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Success Rate
Keywords: Randomized clinical trial
Esthetic crowns
Zirconia crown
Bioflx crown
Primary molars
Deciduous molars
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
Collaborators: name: Jordan University of Science and Technology
First posted: 2025-05-15
Enrollment: 85
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A split mouth randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Currently, prefabricated zirconia crowns have been used as an aesthetic restorative material for primary teeth for a few years. Another recently introduced esthetic crown is the Bioflx™ crown. It is made of a resin polymer and claimed to have high strength , flexibility and durability. The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.

Detailed description: Background: Little is known about aesthetic management of decayed primary posterior teeth in children which often requires full-coverage restorations.

Aim: The aim of this study is to evaluate and compare the clinical and radiographic success of zirconia crowns to that of Bioflx™ crowns in carious primary molars.

Methods: this study design is a split mouth randomized controlled clinical trial including children ages between 4-10 years old. Each patient will receive a zirconia crown and Bioflx™ crown on either side of the maxillary or mandibular arch. Clinical procedure: The patients will be randomly allocated to receive either crown on the first visit, and the other type on the next visit which will be 1-2 weeks after. Children and teeth meeting the inclusion criteria will be included. Crowns will be prepared under local anesthesia and rubber dam isolation. Crowns will be evaluated at 1, 6, 12 and 24-month recall appointments according to pre-set success and failure criteria.

Eligibility criteria: Inclusion Criteria:

* Ages 4-10 years
* Healthy child
* Child is cooperative
* Subject has a minimum of two bilateral carious upper or lower primary molars
* Teeth exhibiting carious lesions clinically and radiographically
* Teeth selected should be fully erupted, with no evidence of tooth fracture, and could be isolated adequately for crown cementation

Exclusion Criteria:

* Tooth close to exfoliation
* Medical problems in sbjects
* Children requiring advanced behaviour management
* Those not available for future recalls/ follow up

Primary outcomes:
measure: Clinically susccessful
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: OLA Al-Batayneh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holsinger DM, Wells MH, Scarbecz M, Donaldson M. Clinical Evaluation and Parental Satisfaction with Pediatric Zirconia Anterior Crowns. Pediatr Dent. 2016;38(3):192-7.
citation: Donly KJ, Sasa I, Contreras CI, Mendez MJC. Prospective Randomized Clinical Trial of Primary Molar Crowns: 24-Month Results. Pediatr Dent. 2018 Jul 15;40(4):253-258.
citation: Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.
citation: Aiem E, Smail-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17.