Different Luting Cements for Pediatric Zirconia Crowns

NCT ID: NCT07152561

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2026-09-01

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Arm 1

Zirconia crown cemented with Predicta® Bioactive Cement

Group Type EXPERIMENTAL

Zirconia crown cemented with Predicta® Bioactive Cement

Intervention Type 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 2

Zirconia crown cemented with resin-cement

Group Type ACTIVE_COMPARATOR

Zirconia crown cemented with resin-cement

Intervention Type 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.

Interventions

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Mohamed Hatem Hanafy

Associate Professor of Pediatric Dentistry and Dental Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Pediatric Zirconia Crowns

Identifier Type: -

Identifier Source: org_study_id

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