Custom-made Versus Prefabricated Zirconia Crowns for Primary Molars.

NCT04620174 | Completed

• 1 other identifier: PD-P-020-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Decayed Teeth

Keywords

Zirconia Crown, Primary teeth

Outcome Measures

Primary Outcomes (1)

• Change in periodontal health.

  The periodontal health will be assessed using the plaque index (PI) and the gingival index (GI)

  At 1, 3, 6 and 12 months following application.

Secondary Outcomes (1)

• Change in clinical performance.

  At 1, 3, 6 and 12 months following application.

Study Arms (2)

Custom-made zirconia crowns Group

OTHER

Ten decayed primary molars will be restored with custom-made zirconia crowns.

Other: Custom-made zirconia crowns

Prefabricated zirconia crowns Group

OTHER

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

Other: Prefabricated zirconia crowns

Interventions

Custom-made zirconia crowns OTHER

Ten decayed primary molars will be restored with custom-made zirconia crowns.

Custom-made zirconia crowns Group

Prefabricated zirconia crowns OTHER

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

Prefabricated zirconia crowns Group

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with systemic health problem.
• Children with periodontal disease.
• Children with unilateral chewing habit or allergic to local anesthesia.
• Presence of parafunctional habit.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Roqaia M Alassar

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Crowns and Bridges, Faculty of Dental Medicine for Girls, Al-Azhar University

Model Details: Three groups will be included; 1. Custom-made Zirconia Crowns Group (10 molars) 2. Prefabricated Zirconia Crowns Group (10 molars)

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 6, 2020
• Study Start: December 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)