A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zirconia crown, Bioflx crown.
- Who it may be relevant to
- Registry conditions: Success Rate. Basic parameters: 4 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Jordan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
Overview
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.
Interventions
- Procedure Zirconia crown
A zirconia esthetic crown will be randomly placed on one side of the jaw - Procedure Bioflx crown
A Bioflx esthetic crown will be randomly placed on one side of the jaw
Primary outcome measures
- Clinically susccessful [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Jordan · 1 center
- Jordan University of Science and Technology — Irbid
Publications
- 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. PMID 27306242
- 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. PMID 30345963
- 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. PMID 25631720
- 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. PMID 27532506
Identifiers
NCT: NCT06973616 · 466-2023