Different Luting Cements for Pediatric Zirconia Crowns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zirconia crown cemented with Predicta® Bioactive Cement, Zirconia crown cemented with resin-cement.
- Who it may be relevant to
- Registry conditions: Dental Caries in Children. Basic parameters: 3 years — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial
Overview
The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.
Detailed description
* For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each. * For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
Interventions
- Drug Zirconia crown cemented with Predicta® Bioactive Cement
• For the bioactive cement group (Predicta® Bioactive Cement), the prepared tooth will be dried using compressed air but not desiccated. Cement will be dispensed through the auto-mixtip directly into the crown, and the crown will be properly positioned over the tooth; cement will be allowed to self-set for 20 seconds while maintaining gentle pressure on the crown. Buccal and lingual margins will be flash-cured for 10 seconds each using a light-curing unit to immediately cure the excess cement fo - Drug Zirconia crown cemented with resin-cement
• For the resin-cement group, the tooth will be dried with compressed air but not desiccated. The sealant will be applied with the syringe; then, the crown will be appropriately positioned over the tooth, and cement will be allowed to self-set for 2 minutes and cured while maintaining gentle pressure on the crown. Excess cement will be removed before the cement is completely set.
Primary outcome measures
- Retention [Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months]
- Fracture [Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months]
Secondary outcome measures (1)
- The gingival condition [Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months]
Eligibility criteria
Inclusion criteria
- Patients who had no history of allergies
- Children who had at least two carious primary incisors.
- Teeth with multi-surface carious lesion.
- Teeth with no percussion or palpation sensitivity
- Teeth with no abscess and/or fistula
- Teeth with no prior pulpal treatment
- Teeth with no mobility or signs of periodontal disease
Exclusion criteria
- Children with congenital developmental defects (such as amelogenesis imperfecta and dentinogenesis imperfecta)
- Children with a history of bruxism, trauma or infraocclusion
- Children with a skeletal or dental malocclusion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07152561 · Pediatric Zirconia Crowns