Skip to main content
Clinical Trials/NCT04479046
NCT04479046
Completed
Not Applicable

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

Ain Shams University1 site in 1 country20 target enrollmentStarted: January 1, 2018Last updated:
ConditionsDecay, Dental

Overview

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Crown survival

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to 8 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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:
  • 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.

Outcomes

Primary Outcomes

Crown survival

Time Frame: 6 months

Fracture

Gingival health

Time Frame: 6 months

Plaque index

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nada Aboushady

Assistant Lecturer

Ain Shams University

Study Sites (1)

Loading locations...

Similar Trials