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Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04620174
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : February 3, 2023
Sponsor:
Information provided by (Responsible Party):
Roqaia Mohammad Alassar, Al-Azhar University

Brief Summary:

Background: Do construction methods of pediatric zirconia crowns affect the periodontal health and clinical performance of badly decayed primary molars? The question asked by many practitioners.

Purpose: to compare the periodontal health and clinical performance of primary molars restored with custom-made and prefabricated zirconia crowns. Hypothesis is the performance of primary molars restored with custom-made zirconia crowns will be equivalent to those restored with prefabricated zirconia crowns.


Condition or disease Intervention/treatment Phase
Decayed Teeth Other: Custom-made zirconia crowns Other: Prefabricated zirconia crowns Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Three groups will be included;

  1. Custom-made Zirconia Crowns Group (10 molars)
  2. Prefabricated Zirconia Crowns Group (10 molars)
  3. Control Group (20 molars)
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars; a Clinical Trial With 12-month Follow-up.
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Custom-made zirconia crowns Group
Ten decayed primary molars will be restored with custom-made zirconia crowns.
Other: Custom-made zirconia crowns
Ten decayed primary molars will be restored with custom-made zirconia crowns.

Prefabricated zirconia crowns Group
Ten decayed primary molars will be restored with prefabricated zirconia crowns.
Other: Prefabricated zirconia crowns
Ten decayed primary molars will be restored with prefabricated zirconia crowns.

Control Group
Twenty intact contralateral teeth will be evaluated as the controls (10 molars will be the controls for custom-made ZrCs and 10 molars will be the controls for prefabricated ZrCs).
Other: Custom-made zirconia crowns
Ten decayed primary molars will be restored with custom-made zirconia crowns.

Other: Prefabricated zirconia crowns
Ten decayed primary molars will be restored with prefabricated zirconia crowns.




Primary Outcome Measures :
  1. Change in periodontal health. [ Time Frame: At 1, 3, 6 and 12 months following application. ]
    The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI)


Secondary Outcome Measures :
  1. Change in clinical performance. [ Time Frame: At 1, 3, 6 and 12 months following application. ]
    The clinical success of the crowns will be assessed in terms of crown retention, marginal adaptation, crown contour, fracture, stain resistance, opposing tooth wear and tooth exfoliation.



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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children of 5-9 years old.
  2. The children have at least 2 decayed primary molars.
  3. Presence of an intact contralateral primary molar as a control.
  4. Willingness to participate and to continue with the follow up appointments.
  5. Clinical and radiographically confirmed dental caries extending to the middle third of dentin.
  6. Presence of teeth in opposite arch with normal occlusion.

Exclusion Criteria:

  1. Children with systemic health problem.
  2. Children with periodontal disease.
  3. Children with unilateral chewing habit or allergic to local anesthesia.
  4. Presence of parafunctional habit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04620174


Contacts
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Contact: Roqaia M Alassar, DDS 01068507055 roqaiaalassar.26@azhar.edu.eg
Contact: Asmaa M Abdelgawad, DDS 01032712141 asmaaabdelgawad.26@azhar.edu.eg

Locations
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Egypt
Roqaia M Alassar Recruiting
Cairo, Egypt, 11765
Contact: Roqaia Alassar, DDS    01068507055    roqaiaalassar.26@azhar.edu.eg   
Contact: Asmaa Abdelgawad, DDS    01032712141    asmaaabdelgawad.26@azhar.edu.eg   
Sponsors and Collaborators
Al-Azhar University
Investigators
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Principal Investigator: Noha I Metwally, DDS Pedodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Principal Investigator: Asmaa M Abdelgawad, DDS Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
Principal Investigator: Roqaia M Alassar, DDS Fixed Prosthodontist, Faculty of Dental Medicine for Girls, Al-Azhar University
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Responsible Party: Roqaia Mohammad Alassar, Lecturer of Crowns and Bridges, Faculty of Dental Medicine for Girls, Al-Azhar University, Al-Azhar University
ClinicalTrials.gov Identifier: NCT04620174    
Other Study ID Numbers: PD-P-020-006
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roqaia Mohammad Alassar, Al-Azhar University:
Zirconia Crown, Primary teeth
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases