An interventional study of Prefabricated Zirconia Crown and Custom-made Zirconia Crowns in Zirconia Crowns, sponsored by Jordan University of Science and Technology. Enrolling by invitation at 1 site in Jordan. Open to participants aged 7 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Tooth preparation and cementation of a suitable size of prefabricated Zirconia crown.
Procedure: Prefabricated Zirconia Crown
Tooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology.
Procedure: Custom-made Zirconia Crowns
Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement.
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.
Rate of Crown retention
Visual-tactile evaluation of the crown retention over time (crown present, loose or lost).
Time frame: 3,6 and 12 months
Rate of chipping and fracture of the crown
Clinical evaluation for the presence/absence of crown chipping or fracture
Time frame: 3,6 and 12 months
Gingival health
Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe \& Silness 1963 )
Time frame: 3,6 and 12 months
Clinical crown margin extension
Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)
Time frame: 3,6 and 12 months
Radiographic crown margin adaptation
Evaluation of crown margin adaptation (Geduk et al., 2023)
Time frame: 6 and 12 months
Clinical crown margin adaptation
Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)
Time frame: 3,6 and 12 months
Time taken for intervention
Total time taken to perform the intervention for each crown (crown preparation, try-in and cementation) in minutes.
Time frame: Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.
Patient satisfaction
Self-reported child acceptance using a 5-points visual analogue scale
Time frame: immediately following intervention.
Patient's comfort
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.
Time frame: peri-operatively
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Jordan University of Science and Technology