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Different Luting Cements for Pediatric Zirconia Crowns

Effect of Two Different Luting Cements on Clinical Outcomes of Pediatric Zirconia Crowns: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07152561
Enrollment
60
Registered
2025-09-03
Start date
2025-08-28
Completion date
2026-09-01
Last updated
2025-09-03

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

Conditions

Dental Caries in Children

Brief summary

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

DRUGZirconia 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 for easier removal, and buccal and lingual surfaces will then be light-cured for an extra 10 seconds each.

DRUGZirconia 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Retention1 week, 1 month, 3 months, 6 months, 9 months, and 12 monthsRetention will be assessed by visual inspection and probe to detect debonded crowns.
Fracture1 week, 1 month, 3 months, 6 months, 9 months, and 12 monthsFractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.

Secondary

MeasureTime frameDescription
The gingival condition1 week, 1 month, 3 months, 6 months, 9 months, and 12 monthsThe gingival condition around cemented crowns will be assessed by calculating the gingival index for each crowned tooth.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026