Zirconia Crowns
Conditions
Keywords
Zirconia crowns, Prefabricated Zirconia crowns, Custom-made Zirconia crowns, Children, Young permanent molars
Brief summary
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
PROCEDUREPrefabricated 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.
PROCEDURECustom-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.
Sponsors
Jordan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Crown retention | 3,6 and 12 months | Visual-tactile evaluation of the crown retention over time (crown present, loose or lost). |
| Rate of chipping and fracture of the crown | 3,6 and 12 months | Clinical evaluation for the presence/absence of crown chipping or fracture |
| Gingival health | 3,6 and 12 months | Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe \& Silness 1963 ) |
| Clinical crown margin extension | 3,6 and 12 months | Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival) |
| Radiographic crown margin adaptation | 6 and 12 months | Evaluation of crown margin adaptation (Geduk et al., 2023) |
| Clinical crown margin adaptation | 3,6 and 12 months | Clinical evaluation of crown margin using an explorer (Geduk et al., 2023) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time taken for intervention | Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented. | Total time taken to perform the intervention for each crown (crown preparation, try-in and cementation) in minutes. |
| Patient satisfaction | immediately following intervention. | Self-reported child acceptance using a 5-points visual analogue scale |
| Patient's comfort | peri-operatively | will be evaluated by an observer (research assistant who will be trained, and calibrated) and recorded using the Sound, Eyes, and motor scale (SEM); Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort. |
Countries
Jordan
Outcome results
None listed