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Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NuSmile Zirconia crowns by NuSmile company

Composite resin strip crowns by 3M company

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring caries, full coverage, strip crown, Zirconia crown, primary anterior teeth, crown

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

NuSmile Zirconia crowns

Composite resin strip crowns

Arm Description

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

Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.

Outcomes

Primary Outcome Measures

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].

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].

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].

Tooth wear of opposing dentition

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

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].

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].

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].

Tooth wear of opposing dentition

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

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].

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].

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].

Tooth wear of opposing dentition

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03184012

First Posted

June 2, 2017

Last Updated

June 8, 2017

Sponsor

King Abdulaziz University

1. Study Identification

Unique Protocol Identification Number

NCT03184012

Brief Title

Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

Official Title

Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 1, 2015 (Actual)

Primary Completion Date

November 1, 2016 (Actual)

Study Completion Date

January 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NuSmile Zirconia crowns

Arm Type

Experimental

Arm Description

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

Arm Title

Composite resin strip crowns

Arm Type

Experimental

Arm Description

Composite resin strip crowns is an esthetic conventional primary anterior crown used to restore carious primary anterior teeth.

Intervention Type

Device

Intervention Name(s)

NuSmile Zirconia crowns by NuSmile company

Intervention Description

anterior carious teeth restored with Zirconia crowns

Intervention Type

Device

Intervention Name(s)

Composite resin strip crowns by 3M company

Intervention Description

anterior carious teeth restored with Strip crowns

Primary Outcome Measure Information:

Title

Gingival Health

Description

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].

Time Frame

3-month follow-up

Title

Plaque index

Description

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].

Time Frame

3-month follow-up

Title

Restoration failure

Description

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

Time Frame

3-month follow-up

Title

Tooth wear of opposing dentition

Description

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

Time Frame

3-month follow-up

Title

Gingival Health

Description

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].

Time Frame

6-month follow-up

Title

Plaque index

Description

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].

Time Frame

6-month follow-up

Title

Restoration failure

Description

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

Time Frame

6-month follow-up

Title

Tooth wear of opposing dentition

Description

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

Time Frame

6-month follow-up

Title

Gingival Health

Description

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].

Time Frame

12-month follow-up

Title

Plaque index

Description

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].

Time Frame

12-month follow-up

Title

Restoration failure

Description

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

Time Frame

12-month follow-up

Title

Tooth wear of opposing dentition

Description

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

Time Frame

12-month follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bashaer S Abdulhadi, MSc

Organizational Affiliation

King Abdulaziz University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33167954

Citation

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.

Results Reference

derived

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Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns

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