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Completed

NCT Number: NCT04479046

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

Evaluation of PMMA pediatric crowns

Completed

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Key information

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain Shams University

Heliopolis, Cairo Governorate, 11737, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children included in the study should conform to the following criteria:
  • Aged 5-8 years old
  • Medically free
  • Patient should suffer from extensively decayed primary lower second molar that will undergo pulpotomy.
  • 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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  • Children who are extremely uncooperative and difficult to manage.
  • Children suffering from any medical conditions that can't be managed in the clinic.
  • Teeth with decay extending beneath the free gingival margin.
  • Teeth that were grossly broken down, that cannot be restored.
  • Presence of uncontrolled bleeding.
  • Clinical or radiographic evidence of non-vitality such as presence of an abscess or a sinus, obvious discoloration, and premature hypermobility.

Treatment and study plan

PMMA crowns

Other

New type of pediatric crowns

Primary outcomes

  1. Gingival health

    Time frame: 6 months

    Plaque index

  2. Crown survival

    Time frame: 6 months

    Fracture

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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