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

Study Overview

• Status: Completed
• Conditions: Decay, Dental
• Intervention / Treatment: Other: PMMA 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Heliopolis, Cairo, Egypt, 11737
      • Faculty of dentistry, ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stainless steel crowns; 3M ESPE	Other: PMMA crowns; New type of pediatric crowns
Experimental: Zirconia crowns; Nu Smile	Other: PMMA crowns; New type of pediatric crowns
Experimental: PMMA crowns; Dental Direkt	Other: PMMA crowns; New type of pediatric crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival health	Plaque index	6 months
Crown survival	Fracture	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: NAP202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No