A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars

NCT06973616 | Enrolling By Invitation

• 1 other identifier: 466-2023
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Success Rate

Keywords

Randomized clinical trial; Esthetic crowns; Zirconia crown; Bioflx crown; Primary molars; Deciduous molars

Outcome Measures

Primary Outcomes (1)

• Clinically susccessful

  Normal gingiva (no inflammation or edema) Normal occlusion (not high in occlusion) Parent satisfied (as reported) Child satisfied (as reported)

  24 months

Study Arms (2)

Zirconia esthetic crowns

ACTIVE COMPARATOR

Zirconia esthetic crowns

Procedure: Zirconia crown

Bioflx esthetic crowns

ACTIVE COMPARATOR

Bioflx esthetic crowns

Procedure: Bioflx crown

Interventions

Zirconia crown PROCEDURE

A zirconia esthetic crown will be randomly placed on one side of the jaw

Also known as: Esthetic crown

Zirconia esthetic crowns

Bioflx crown PROCEDURE

A Bioflx esthetic crown will be randomly placed on one side of the jaw

Also known as: Esthetic crown

Bioflx esthetic crowns

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Study Officials

• OLA Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A split mouth randomized clinical trial

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: January 2, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)