Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent 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: Prefabricated Zirconia Crown, Custom-made Zirconia Crowns.
- Who it may be relevant to
- Registry conditions: Zirconia Crowns. Basic parameters: 7 years — 13 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
Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial
Overview
This study aims to compare the clinical performance of Prefabricated Zirconia Crowns (PZCs) with that of Custom-made Zirconia Crowns (CZCs) using enhanced clinical protocols.
Detailed description
Young permanent molars presenting with gross caries, pulpal treatment or developmental defects often require full coverage restorations. Recently, the Prefabricated Zirconia Crowns (PZCs) have been introduced as a biocompatible and an aesthetically pleasant option with promising outcomes. However, it comes in specific sizes, limited shades and a significant tooth preparation is often required. Custom-made zirconia crowns (CZCs), fabricated using CAD/CAM technology may; offer a favorable aesthetic alternative by ensuring a controlled tooth reduction, precise fit, better aesthetics, and improved retention. Nevertheless, the current evidence concerning its use in young permanent molars remains limited. This study will be a randomised clinical trial that aims to compare the clinical performance of (PZCs) with that of (CZCs) for the restoration of badly carious/destructed young permanent molars in children aged 7-13. Patients will be randomised into two treatment groups using an online block randomisation technique (block size of 6) and sealed-envelope techniques. Clinical parameters: retention, fracture, gingival health and marginal integrity will be evaluated at 3-month, 6-month, and 12-month intervals. In addition, treatment duration, intraoperative patient comfort and immediate postoperative patient satisfaction will be evaluated and compared. The findings of this study are expected to provide evidence on the suitability of CZC for young permanent molars in children. The Null hypothesis is that there is no difference between the two types of crowns in terms of clinical performance and child acceptance.
Interventions
- Procedure Prefabricated Zirconia Crown
Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement. - Procedure Custom-made Zirconia Crowns
Tooth preparation (1-1.5 mm occlusal, 0.5 to 1.25 mm circumferential, with a shoulder-edge supra-gingival margin), followed by scanning with an intra-oral scanner, then temporisation. A zirconia crown will be produced using CAD-CAM technology and cemented with a self-adhesive resin cement on a different visit.
Primary outcome measures
- Rate of Crown retention [Time frame: 3,6 and 12 months]
- Rate of chipping and fracture of the crown [Time frame: 3,6 and 12 months]
- Gingival health [Time frame: 3,6 and 12 months]
- Clinical crown margin extension [Time frame: 3,6 and 12 months]
- Radiographic crown margin adaptation [Time frame: 6 and 12 months]
- Clinical crown margin adaptation [Time frame: 3,6 and 12 months]
Secondary outcome measures (3)
- Time taken for intervention [Time frame: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.]
- Patient satisfaction [Time frame: immediately following intervention.]
- Patient's comfort [Time frame: peri-operatively]
Eligibility criteria
Inclusion criteria
- Medically fit or with mild systemic illness (ASA I or II).
- Children who assent to take part in the study with a valid parental consent
- Children who have at least one first permanent molar requiring a full-coverage restoration (indications for placing a crown include: badly destructed/carious molars, or teeth affected by molar-incisor hypomineralisation (MIH))
- Maxillary or mandibular fully erupted first permanent molars, regardless of the stage of root development.
- A cooperative child that accepts dental treatment (Frankle Behaviour Rating Scale #3 or 4).
- Capable of attending all follow-up sessions.
Exclusion criteria
- Patients outside the required age range
- Parents/child not willing to participate.
- Medically compromised patients
- Partially erupted permanent first molars.
- Patients with severe malocclusion that prohibits the provision of crowns
- First permanent molars are not indicated for full coverage restorations.
- First permanent molars are indicated for extraction.
- Patients with bruxism or parafunctional habits.
- Uncooperative children (Frankle Behaviour Rating Scale #1 or 2)
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
Identifiers
NCT: NCT07704151 · 245-2025