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Enrolling by Invitation

NCT Number: NCT06973616

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

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.

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Key information

Conditions

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zirconia crown

Procedure

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

Other names: Esthetic crown

Bioflx crown

Procedure

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

Other names: Esthetic crown

Primary outcomes

  1. Clinically susccessful

    Time frame: 24 months

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

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 15, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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