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

N/ANot Yet RecruitingNCT07738471

Cairo University64 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Molar Tooth Pulpotomies Primary Teeth

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: 12month

Secondary Outcomes

Mean Gingival index

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.

Time frame: 12month