Back to resultsEvaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Primary Purpose
Decay, Dental
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PMMA crowns
Sponsored by
About this trial
This is an interventional treatment trial for Decay, Dental
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry, Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Stainless steel crowns
Zirconia crowns
PMMA crowns
Arm Description
3M ESPE
Nu Smile
Dental Direkt
Outcomes
Primary Outcome Measures
Gingival health
Plaque index
Crown survival
Fracture
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04479046
Brief Title
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Official Title
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decay, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stainless steel crowns
Arm Type
Active Comparator
Arm Description
3M ESPE
Arm Title
Zirconia crowns
Arm Type
Experimental
Arm Description
Nu Smile
Arm Title
PMMA crowns
Arm Type
Experimental
Arm Description
Dental Direkt
Intervention Type
Other
Intervention Name(s)
PMMA crowns
Intervention Description
New type of pediatric crowns
Primary Outcome Measure Information:
Title
Gingival health
Description
Plaque index
Time Frame
6 months
Title
Crown survival
Description
Fracture
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry, Ain Shams University
City
Heliopolis
State/Province
Cairo
ZIP/Postal Code
11737
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluating the Efficiency of Newly Designed Prefabricated PMMA Crowns for Restoring Primary Teeth in Comparison to Stainless Steel and Zirconia Crowns
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