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Enrolling by Invitation

NCT Number: NCT07704151

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars

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.

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Key information

Conditions

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Prefabricated Zirconia Crown

Procedure

Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement.

Custom-made Zirconia Crowns

Procedure

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 outcomes

  1. Rate of Crown retention

    Time frame: 3,6 and 12 months

    Visual-tactile evaluation of the crown retention over time (crown present, loose or lost).

  2. Rate of chipping and fracture of the crown

    Time frame: 3,6 and 12 months

    Clinical evaluation for the presence/absence of crown chipping or fracture

  3. Gingival health

    Time frame: 3,6 and 12 months

    Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe & Silness 1963 )

  4. Clinical crown margin extension

    Time frame: 3,6 and 12 months

    Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)

  5. Radiographic crown margin adaptation

    Time frame: 6 and 12 months

    Evaluation of crown margin adaptation (Geduk et al., 2023)

  6. Clinical crown margin adaptation

    Time frame: 3,6 and 12 months

    Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)

Secondary outcomes

  1. Time taken for intervention

    Time frame: 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.

  2. Patient satisfaction

    Time frame: immediately following intervention.

    Self-reported child acceptance using a 5-points visual analogue scale

  3. Patient's comfort

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

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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