Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Dental Caries Clinical Trial

Official title:

Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184012
• Other study ID #: King Abdulaziz University
• Status: Completed
• Phase: N/A
• First received: June 2, 2017
• Last updated: June 8, 2017
• Start date: November 1, 2015
• Est. completion date: January 30, 2017

Study information

• Verified date: June 2017
• Source: King Abdulaziz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2017
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

Device:
• NuSmile Zirconia crowns by NuSmile company
anterior carious teeth restored with Zirconia crowns
• Composite resin strip crowns by 3M company
anterior carious teeth restored with Strip crowns

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Abdulaziz University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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