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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07738471

Enrollment

Registered

2026-07-31

Start date

2026-11-01

Completion date

2027-11-01

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Molar Tooth, Pulpotomies Primary Teeth

Keywords

Zirconia Crown, Customer

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.

Interventions

DEVICECustom made zirconia crowns

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

DEVICEPrefabricated zirconia crown

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 8 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Clinical sucess	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

Measure	Time frame	Description
Mean Gingival index	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026