NCT07704151

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Aug 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Aug 2025Dec 2027

Study Start

First participant enrolled

August 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

March 25, 2026

Last Update Submit

July 9, 2026

Conditions

Zirconia Crowns

Keywords

Zirconia crownsPrefabricated Zirconia crownsCustom-made Zirconia crownsChildrenYoung permanent molars

Outcome Measures

Primary Outcomes (6)

  • Rate of Crown retention

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

    3,6 and 12 months

  • Rate of chipping and fracture of the crown

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

    3,6 and 12 months

  • Gingival health

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

    3,6 and 12 months

  • Clinical crown margin extension

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

    3,6 and 12 months

  • Radiographic crown margin adaptation

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

    6 and 12 months

  • Clinical crown margin adaptation

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

    3,6 and 12 months

Secondary Outcomes (3)

  • Time taken for intervention

    Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.

  • Patient satisfaction

    immediately following intervention.

  • Patient's comfort

    peri-operatively

Study Arms (2)

Prefabricated Zirconia Crowns

EXPERIMENTAL

Tooth preparation and cementation of a suitable size of prefabricated Zirconia crown.

Procedure: Prefabricated Zirconia Crown

Custom-made Zirconia Crowns

EXPERIMENTAL

Tooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology.

Procedure: Custom-made Zirconia Crowns

Interventions

Prefabricated Zirconia CrownPROCEDURE

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

Prefabricated Zirconia Crowns
Custom-made Zirconia CrownsPROCEDURE

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.

Custom-made Zirconia Crowns

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, Jordan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

July 15, 2026

Study Start

August 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Locations

JO(1)