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Trial record 21 of 119 for:    ZIRCONIUM

Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03184012
Recruitment Status : Completed
First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Bashaer S. Abdulhadi, King Abdulaziz University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Caries Device: NuSmile Zirconia crowns by NuSmile company Device: Composite resin strip crowns by 3M company Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns
Actual Study Start Date : November 1, 2015
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: NuSmile Zirconia crowns
NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.
Device: NuSmile Zirconia crowns by NuSmile company
anterior carious teeth restored with Zirconia crowns

Experimental: Composite resin strip crowns
Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.
Device: Composite resin strip crowns by 3M company
anterior carious teeth restored with Strip crowns




Primary Outcome Measures :
  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)



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184012


Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Bashaer S Abdulhadi, MSc King Abdulaziz University

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Responsible Party: Bashaer S. Abdulhadi, Dr. Bashaer Abdulhadi, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03184012     History of Changes
Other Study ID Numbers: King Abdulaziz University
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bashaer S. Abdulhadi, King Abdulaziz University:
caries
full coverage
strip crown
Zirconia crown
primary anterior teeth
crown
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases