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Not yet recruiting NCT07738471

Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars

No phase Interventional Primary Molar Tooth Pulpotomies Primary Teeth

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: Custom made zirconia crowns, Prefabricated zirconia crown.
Who it may be relevant to
Registry conditions: Primary Molar Tooth, Pulpotomies Primary Teeth. Basic parameters: 5 years — 8 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars: A Randomized Clinical Trial

Overview

Early childhood caries often results in extensive destruction of primary molars, requiring pulpotomy followed by full-coronal restoration to ensure long-term function and durability. Zirconia crowns have become a popular esthetic restorative option; however, limited evidence is available regarding the clinical performance of custom-made zirconia crowns compared with prefabricated zirconia crowns. This randomized controlled clinical trial aims to compare the clinical performance of custom-made and prefabricated zirconia crowns placed on pulpotomized primary molars. Clinical performance will be evaluated using standardized clinical and radiographic outcome measures over the follow-up period to determine whether custom-made zirconia crowns provide comparable or improved outcomes.

Interventions

  • Device Custom made zirconia crowns
    Participants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol.
  • Device Prefabricated zirconia crown
    prefabricated zirconia crown selected according to tooth size and cemented on pulpotomized primary molars

Primary outcome measures

  • Clinical sucess [Time frame: 12month]
Secondary outcome measures (1)
  • Mean Gingival index [Time frame: 12month]

Eligibility criteria

Inclusion criteria

  • Children aged 5-8 years.
  • Primary molars with deep carious lesions extending to the middle third of the dentin as confirmed radiographically.
  • Absence of root caries.
  • Absence of periapical or inter-radicular radiolucency.
  • Absence of internal or external root resorption.
  • Teeth in the opposite arch are present and in normal occlusion.
  • Willingness to participate and adhere to the follow-up appointments

Exclusion criteria

  • Children with systemic health issues.
  • Children with periodontal diseases.
  • Children exhibiting parafunctional habits.
  • Uncooperative children (Frankl scale (score 1 and 2).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07738471 · * PEDO-PHD-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗