Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

NCT03184012 | Completed DMC FDA Device

• 1 other identifier: King Abdulaziz University
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries

Keywords

caries; full coverage; strip crown; Zirconia crown; primary anterior teeth; crown

Outcome Measures

Primary Outcomes (12)

• Gingival Health

  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-month follow-up

• Plaque index

  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-month follow-up

• Restoration failure

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

  3-month follow-up

• Tooth wear of opposing dentition

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

  3-month follow-up

• Gingival Health

  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-month follow-up

• Plaque index

  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-month follow-up

• Restoration failure

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

  6-month follow-up

• Tooth wear of opposing dentition

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

  6-month follow-up

• Gingival Health

  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 \[Löe, 1967\].

  12-month follow-up

• Plaque index

  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 \[Löe, 1967\].

  12-month follow-up

• Restoration failure

  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-month follow-up

• Tooth wear of opposing dentition

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

  12-month follow-up

Study Arms (2)

NuSmile Zirconia crowns

EXPERIMENTAL

NuSmile Zirconia crowns is an esthetic primary anterior crown used to restore carious primary anterior teeth.

Device: NuSmile Zirconia crowns by NuSmile company

Composite resin strip crowns

EXPERIMENTAL

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

Interventions

NuSmile Zirconia crowns by NuSmile company DEVICE

anterior carious teeth restored with Zirconia crowns

NuSmile Zirconia crowns

Composite resin strip crowns by 3M company DEVICE

anterior carious teeth restored with Strip crowns

Composite resin strip crowns

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdulaziz University: lead

Related Publications (1)

• Alaki SM, Abdulhadi BS, AbdElBaki MA, Alamoudi NM. Comparing zirconia to anterior strip crowns in primary anterior teeth in children: a randomized clinical trial. BMC Oral Health. 2020 Nov 10;20(1):313. doi: 10.1186/s12903-020-01305-1.

  PMID: 33167954 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Bashaer S Abdulhadi, MSc

  King Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bashaer Abdulhadi

Model Details: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 12, 2017
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: January 30, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share