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Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

K

King Abdulaziz University

Status

Completed

Conditions

Dental Caries

Treatments

Device: NuSmile Zirconia crowns by NuSmile company
Device: Composite resin strip crowns by 3M company

Study type

Interventional

Funder types

Other

Identifiers

NCT03184012
King Abdulaziz University

Details and patient eligibility

About

The hypothesis to be investigated is that no difference will be found upon comparing resin composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in restoring anterior primary teeth.

Full description

The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary anterior crowns, compared with anterior resin composite strip crowns in the restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous dentition of child patients).

Enrollment

120 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
  • Minimal of two surfaces of caries in the targeted tooth.
  • Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD), 2016.
  • Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
  • Opposing teeth present.
  • Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomfort, risks, and benefits.
  • No patient was excluded on the basis of gender, race, social or economic background.

Exclusion criteria

  • Teeth with proximity to exfoliation and resorption of the root passed its half.
  • Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
  • Presence of single surface caries not involving the proximal surfaces.
  • Teeth that has been subjected to trauma.
  • Anxious, uncooperative patients who need to be treated under general anesthesia.
  • Children who suffer from bruxism.
  • Children with special needs.
  • Presence of tooth wear on the opposing teeth (in case of anterior teeth), or absence of opposing.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

NuSmile Zirconia crowns
Experimental group
Description:
NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.
Treatment:
Device: NuSmile Zirconia crowns by NuSmile company
Composite resin strip crowns
Experimental group
Description:
Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.
Treatment:
Device: Composite resin strip crowns by 3M company

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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