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

NCT07738471 | Not Yet Recruiting DMC

• 1 other identifier: * PEDO-PHD-2026-001
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Molar Tooth; Pulpotomies Primary Teeth

Keywords

Zirconia Crown; Customer

Outcome Measures

Primary Outcomes (1)

• Clinical sucess

  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.

  12month

Secondary Outcomes (1)

• Mean Gingival index

  12month

Study Arms (2)

Custom-Made Zirconia Crowns

EXPERIMENTAL

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

Device: Custom made zirconia crowns

: Prefabricated Zirconia Crowns

ACTIVE COMPARATOR

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

Device: Custom made zirconia crowns; Device: Prefabricated zirconia crown

Interventions

Custom made zirconia crowns DEVICE

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

: Prefabricated Zirconia Crowns; Custom-Made Zirconia Crowns

Prefabricated zirconia crown DEVICE

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

: Prefabricated Zirconia Crowns

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share