About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Children with systemic health issues.
Children with periodontal diseases.
Children exhibiting parafunctional habits.
Uncooperative children (Frankl scale (score 1 and 2).
Trial design
Parallel
Treatments tested in this trial
Custom made zirconia crowns
DeviceParticipants will receive custom-made zirconia crowns placed on pulpotomized primary molars according to the study protocol.
Prefabricated zirconia crown
Deviceprefabricated zirconia crown selected according to tooth size and cemented on pulpotomized primary molars
Treatment groups
Trial 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.
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.
Locations
Sponsors and contacts
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