Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns

NCT ID: NCT04479046

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-01

Brief Summary

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Evaluation of PMMA pediatric crowns

Detailed Description

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The aim of the present study is to evaluate the PMMA crowns regarding the following aspects:

I. Clinical evaluation of PMMA crowns regarding wear of opposing teeth when compared to zirconia crowns and stainless steel crowns after 6 months, and 12 months.

II. Color stability of PMMA crowns and zirconia crowns after 6 months, and 12 months.

III. Gingival health of restored teeth after 6 months, and 12 months. IV. Patient's satisfaction regarding the appearance and clinical performance of PMMA crowns when compared to stainless steel crowns and zirconia crowns through a given questionnaire.

Conditions

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Decay, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stainless steel crowns

3M ESPE

Group Type ACTIVE_COMPARATOR

PMMA crowns

Intervention Type OTHER

New type of pediatric crowns

Zirconia crowns

Nu Smile

Group Type EXPERIMENTAL

PMMA crowns

Intervention Type OTHER

New type of pediatric crowns

PMMA crowns

Dental Direkt

Group Type EXPERIMENTAL

PMMA crowns

Intervention Type OTHER

New type of pediatric crowns

Interventions

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PMMA crowns

New type of pediatric crowns

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children included in the study should conform to the following criteria:

1. Aged 5-8 years old
2. Medically free
3. Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
4. The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.

Exclusion Criteria

Children with the following criteria will be totally excluded from the study:

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1. Children who are extremely uncooperative and difficult to manage.
2. Children suffering from any medical conditions that can't be managed in the clinic.
3. Teeth with decay extending beneath the free gingival margin.
4. Teeth that were grossly broken down, that cannot be restored.
5. Presence of uncontrolled bleeding.
6. Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nada Aboushady

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Ain Shams University

Heliopolis, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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NAP202

Identifier Type: -

Identifier Source: org_study_id

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