Health TrialsbyHealthPanel

Different Luting Cements for Pediatric Zirconia Crowns

ConditionDental Caries in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-5
SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Retention

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

Time frame
1 week, 1 month, 3 months, 6 months, 9 months, and 12 months
2

Fracture

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

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

Secondary outcomes

1

The gingival condition

The gingival condition around cemented crowns will be assessed by calculating the gingival index for each crowned tooth.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: