Trials / Enrolling By Invitation
Enrolling By InvitationNCT06973616
A Clinical Trial of Two Types of Aesthetics Crowns for Primary Molars
A Prospective Randomized Clinical Trial of Two Types of Aesthetics Crowns Used in Restoration of Carious Primary Molars
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- Sponsor
- King Abdullah University Hospital · Academic / Other
- Sex
- All
- Age
- 4 Years – 10 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-01-02
- Primary completion
- 2025-12-30
- Completion
- 2026-12-30
- First posted
- 2025-05-15
- Last updated
- 2025-05-15
Locations
1 site across 1 country: Jordan
Source: ClinicalTrials.gov record NCT06973616. Inclusion in this directory is not an endorsement.