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NCT Number: NCT07152561

Different Luting Cements for Pediatric Zirconia Crowns

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

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Retention

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

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

  2. Fracture

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

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

Secondary outcomes

  1. The gingival condition

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

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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