Clinical Outcomes of Digital vs Prefab Crowns for Pulpotomized Primary Molars

NCT06733909 | Recruiting

• 1 other identifier: 2024-2
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

NuSmile Zirconia crowns: Prefabricated pediatric Zirconia crowns offer an excellent alternative to full-coverage crowns when restoring deciduous teeth with a sizeable carious defect. These crowns have high flexural strength, allowing them to resist crack propagation. The additional benefits of these crowns are the ability to replace metals due to extremely high strength and toughness, higher resistance to chemicals, and superior erosion resistance. Zirconia crowns are biocompatible, autoclavable, and equal to or more durable than natural enamel.

Conditions

Pulpotomized Primary Molars

Outcome Measures

Primary Outcomes (1)

• Clinical success

  aesthetics, functional and biological criteria of the restorations

  12 months

Study Arms (3)

NuSmile Zirconia crowns

ACTIVE COMPARATOR

Prefabricated pediatric Zirconia crowns offer an excellent alternative to full-coverage crowns when restoring deciduous teeth with a sizeable carious defect

Other: Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns

BioFlx crowns

EXPERIMENTAL

The Bioflex crown has been introduced in pediatric practice as a synthetic crown that will provide better adaptation, durability, and ease of handling with improved aesthetic properties compared to conventional crowns

Other: Restoration of Pulpotomized Primary Molars using BioFlx crowns

Digital VITA ENAMIC crowns

EXPERIMENTAL

is a hybrid ceramic with a dual network structure that combines the best characteristics of ceramic and composite. Fast and efficient CAM fabrication; for minimally invasive reconstructions, tooth-like material properties.

Other: Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks)

Interventions

Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns OTHER

Prefabricated pediatric Zirconia crowns offer an excellent alternative to full-coverage crowns when restoring deciduous teeth with a sizeable carious defect. These crowns have high flexural strength, allowing them to resist crack propagation. The additional benefits of these crowns are the ability to replace metals due to extremely high strength and toughness, higher resistance to chemicals, and superior erosion resistance

NuSmile Zirconia crowns

Restoration of Pulpotomized Primary Molars using BioFlx crowns OTHER

The Bioflex crown has been introduced in pediatric practice as a synthetic crown that will provide better adaptation, durability, and ease of handling with improved aesthetic properties compared to conventional crowns. The Bioflex crown may provide a promising result in terms of the clinician's and parental satisfaction as aesthetic is a prime concern for parents and children in this era. The limitations of the studies on this type of crowns will require more studies with more detailed clinical observation and larger sample size to provide more rigorous results.

BioFlx crowns

Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks) OTHER

is a hybrid ceramic with a dual network structure that combines the best characteristics of ceramic and composite. Fast and efficient CAM fabrication; for minimally invasive reconstructions, tooth-like material properties.

Digital VITA ENAMIC crowns

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 5 and 9 years old.
• Positively cooperative children.
• Children having a restorable pulpotomized primary tooth.
• Primary molars with no spontaneous or provoked pain
• Teeth to be included should be fully erupted, have functional occlusion.
• The crowned molar is in contact with at least one adjacent molar medially with primary first molar and- or laterally with permanent first molar (standard for posterior crowns).

You may not qualify if:

• Patients with systemic diseases (congenital or rheumatic heart disease, hepatitis, nephritis, tumor, cyclic neutropenia, leukemia, and children on long-term corticosteroid therapy).
• Un-cooperative patients.
• The child having oral parafunctional habits
• Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries).

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

MSA University

El-Sheikh Zayed City, Giza Governorate, 16672, Egypt

RECRUITING

Central Study Contacts

Marwa Salamon,, Ph.D

CONTACT

+20 101 655 5055; maasalmon@msa.edu.eg

Mahmoud Attia, Ph.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: December 13, 2024
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)