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NCT Number: NCT07738471

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

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.

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Key information

Conditions

Primary Molar Tooth Pulpotomies Primary Teeth

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Custom made zirconia crowns

Device

Participants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol.

Prefabricated Zirconia Crown

Device

prefabricated zirconia crown selected according to tooth size and cemented on pulpotomized primary molars

Primary outcomes

  1. Clinical sucess

    Time frame: 12month

    Clinical success will be determined according to the Modified USPHS criteria. Overall clinical success will be based on the combined assessment of marginal adaptation, retention, crown contour, and fracture.

Secondary outcomes

  1. Mean Gingival index

    Time frame: 12month

    Mean Gingival Index Score

    Gingival health will be assessed using the Gingival Index with a William periodontal probe.

    Score 0: Normal gingiva.

    Score 1: Mild inflammation with slight color change.

    Score 2: Moderate inflammation with redness and bleeding on probing.

    Score 3: Severe inflammation with edema, redness, ulceration, and spontaneous or probing-induced bleeding.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 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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