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

Not Applicable

Completed

• Conditions: Decay, Dental
• Interventions: Other: PMMA crowns

• Registration Number: NCT04479046
• Lead Sponsor: Ain Shams University

Brief Summary

Evaluation of PMMA pediatric crowns

Detailed Description

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-06-01
• Study First Submitted: 2019-12-27
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMMA crowns	PMMA crowns	Dental Direkt
Zirconia crowns	PMMA crowns	Nu Smile
Stainless steel crowns	PMMA crowns	3M ESPE

Primary Outcome Measures

Name	Time	Method
Crown survival	6 months	Fracture
Gingival health	6 months	Plaque index

Trial Locations

Locations (1)

Faculty of Dentistry, Ain Shams University; 🇪🇬 Heliopolis, Cairo, Egypt