Different Luting Cements for Pediatric Zirconia Crowns

NCT07152561 | Not Yet Recruiting

• 1 other identifier: Pediatric Zirconia Crowns
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to compare the efficacy of using bioactive cement versus resin-cement for cementation of anterior pediatric zirconia crowns.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (2)

• Retention

  Retention will be assessed by visual inspection and probe to detect debonded crowns.

  1 week, 1 month, 3 months, 6 months, 9 months, and 12 months

• Fracture

  Fractures will be assessed using visual inspection to detect incomplete fracture lines or complete fractures with loss of crown material.

  1 week, 1 month, 3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (1)

• The gingival condition

  1 week, 1 month, 3 months, 6 months, 9 months, and 12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Zirconia crown cemented with Predicta® Bioactive Cement

Drug: Zirconia crown cemented with Predicta® Bioactive Cement

Arm 2

ACTIVE COMPARATOR

Zirconia crown cemented with resin-cement

Drug: Zirconia crown cemented with resin-cement

Interventions

Zirconia crown cemented with Predicta® Bioactive Cement DRUG

• 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.

Arm 1

Zirconia crown cemented with resin-cement DRUG

• 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.

Arm 2

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Resin Cements

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Dentistry and Dental Public Health

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08