Clinical Outcomes of Digital vs Prefab Crowns for Pulpotomized Primary Molars
NCT ID: NCT06733909
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
102 participants
INTERVENTIONAL
2023-12-01
2025-01-01
Brief Summary
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Detailed Description
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BioFlx crowns: 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. Digital VITA ENAMIC crowns (CAD/CAM blanks): 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. Vita Enamic has an 9 elastic modulus of 30-32 GPa and resembles dental hard tissues, enabling it to mimic the biomechanical properties of natural teeth. Moreover, Vita Enamic has the advantage of preserving the antagonist teeth from abrasion and performing better at heavy occlusal stresses because it has the ability to resist crack initiation and progression. CAD/CAM technology is an innovative method of producing indirect restorations in primary teeth. With the help of the design software, the clinician can produce ideal occlusal and proximal contact points and a better marginal fit at the gingival wall. Moreover, it involves a shorter clinical working time which is beneficial for children's patients, less wear of the opposing dentition, and the choice of more biocompatible materials. However, there are limited cases of restorations on primary teeth with CAD/CAM technology Computer-aided design and manufacturing (CAD/CAM) technology have made enormous improvements since its introduction. Nowadays, this technology is available directly in dental clinics and it is capable, via its software, of fabricating (customized) full ceramic crowns, inlays, onlays, and veneers for permanent dentition at one appointment.
To date, most clinical studies of prefabricated crowns have been conducted on anterior teeth. There is a lack of information regarding the longevity of such crowns on primary teeth. Therefore, the objective of the present study was to evaluate the clinical success rate of NuSmile pediatric Zirconia, BioFlx crowns and Digital VITA ENAMIC crowns (CAD/CAM blanks) using 3 Shape TRIOS® Intraoral Scanner in primary posterior teeth up to one year.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NuSmile Zirconia crowns
Prefabricated pediatric Zirconia crowns offer an excellent alternative to full-coverage crowns when restoring deciduous teeth with a sizeable carious defect
Restoration of Pulpotomized Primary Molars using 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
BioFlx crowns
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
Restoration of Pulpotomized Primary Molars using BioFlx crowns
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.
Digital VITA ENAMIC crowns
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.
Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks)
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.
Interventions
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Restoration of Pulpotomized Primary Molars using 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
Restoration of Pulpotomized Primary Molars using BioFlx crowns
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.
Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks)
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.
Eligibility Criteria
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Inclusion Criteria
2. Positively cooperative children.
3. Children having a restorable pulpotomized primary tooth.
4. Primary molars with no spontaneous or provoked pain
5. Teeth to be included should be fully erupted, have functional occlusion.
6. 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).
Exclusion Criteria
2. Un-cooperative patients.
3. The child having oral parafunctional habits
4. Un-restorable primary molars (Grossly broken-down primary molars that have decay extending way under the gingiva and tooth with root caries).
5 Years
9 Years
ALL
Yes
Sponsors
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October University for Modern Sciences and Arts
OTHER
Responsible Party
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Locations
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MSA University
El-Sheikh Zayed City, Giza Governorate, Egypt
Countries
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Central Contacts
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Mahmoud Attia, Ph.D
Role: CONTACT
Facility Contacts
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Yomna A.Azim, Ph. D
Role: primary
Other Identifiers
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2024-2
Identifier Type: -
Identifier Source: org_study_id