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Completed

NCT Number: NCT03184012

Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

NuSmile Zirconia crowns by NuSmile company

Device

anterior carious teeth restored with Zirconia crowns

Composite resin strip crowns by 3M company

Device

anterior carious teeth restored with Strip crowns

Primary outcomes

  1. Gingival Health

    Time frame: 3-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].

  2. Plaque index

    Time frame: 3-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe,1967].

  3. Restoration failure

    Time frame: 3-month follow-up

    This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].

  4. Tooth wear of opposing dentition

    Time frame: 3-month follow-up

    Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)

  5. Gingival Health

    Time frame: 6-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].

  6. Plaque index

    Time frame: 6-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].

  7. Restoration failure

    Time frame: 6-month follow-up

    This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].

  8. Tooth wear of opposing dentition

    Time frame: 6-month follow-up

    Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)

  9. Gingival Health

    Time frame: 12-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].

  10. Plaque index

    Time frame: 12-month follow-up

    This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index [Löe, 1967].

  11. Restoration failure

    Time frame: 12-month follow-up

    This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service "USPHS", Alpha criteria rating system [Ryge, 1980].

  12. Tooth wear of opposing dentition

    Time frame: 12-month follow-up

    Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984)

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 12, 2017
Registry last updated
Jun 12, 2017

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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