A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars
NCT ID: NCT06973616
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
85 participants
INTERVENTIONAL
2024-01-02
2026-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Zirconia esthetic crowns
Zirconia esthetic crowns
Zirconia crown
A zirconia esthetic crown will be randomly placed on one side of the jaw
Bioflx esthetic crowns
Bioflx esthetic crowns
Bioflx crown
A Bioflx esthetic crown will be randomly placed on one side of the jaw
Interventions
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Zirconia crown
A zirconia esthetic crown will be randomly placed on one side of the jaw
Bioflx crown
A Bioflx esthetic crown will be randomly placed on one side of the jaw
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Medical problems in sbjects
* Children requiring advanced behaviour management
* Those not available for future recalls/ follow up
4 Years
10 Years
ALL
Yes
Sponsors
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Jordan University of Science and Technology
OTHER
King Abdullah University Hospital
OTHER
Responsible Party
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Principal Investigators
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OLA Al-Batayneh
Role: PRINCIPAL_INVESTIGATOR
Jordan University of Science and Technology
Locations
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Jordan University of Science and Technology
Irbid, , Jordan
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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466-2023
Identifier Type: -
Identifier Source: org_study_id
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