Pulpotomized Primary MolarsNCT06733909
Clinical Outcomes of Digital vs Prefab Crowns for Pulpotomized Primary Molars
A study testing Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns, Restoration of Pulpotomized Primary Molars using BioFlx crowns and Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks) in people with Pulpotomized Primary Molars, run by October University for Modern Sciences and Arts at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomized Primary Molars
- What is being tested?
- Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns, Restoration of Pulpotomized Primary Molars using BioFlx crowns and Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Mahmoud Attia, Ph.D contact
Egypt1 site, 1 recruiting
- Recruiting
MSA University
El-Sheikh Zayed City, Giza Governorate, 16672
Yomna A.Azim, Ph. D
About this study
Official title: Clinical Evaluation of Digital Versus Prefabricated Primary Crowns For Restoration of Pulpotomized Primary Molars: A Randomized Clinical Trial
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.
Read the detailed description
Since the introduction of primary Zirconia crowns, several studies have reported their clinical success. Severely mutilated primary anterior teeth showed that NuSmile Zirconia crowns (NuSmile Ltd., Houston, TX, United States) offered superior esthetics and durability with remarkable gingival responses up to 24 months. A clinical study on the wear behavior of primary enamel against Zirconia crowns demonstrated the lowest wear rate of primary enamel. A retrospective study that evaluated the clinical success and parental satisfaction showed a considerable percentage (89%) of parents were highly satisfied by the crowns' size, color, and form.
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
- Pulpotomized Primary Molars
- Being tested
- Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns, Restoration of Pulpotomized Primary Molars using BioFlx crowns, Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crownsOther
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 crownsOther
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Other: Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
aesthetics, functional and biological criteria of the restorations
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Dec 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpotomized Primary MolarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733909
- Sponsor's protocol ID
- 2024-2
- Status last verified
- Apr 2024
- First submitted
- 28 May 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Digital Versus Prefabricated Primary Crowns For Restoration of Pulpotomized Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06733909
- Acronym / sponsor ID
- 2024-2
- Conditions
- Pulpotomized Primary Molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Since the introduction of primary Zirconia crowns, several studies have reported their clinical success. Severely mutilated primary anterior teeth showed that NuSmile Zirconia crowns (NuSmile Ltd., Houston, TX, United States) offered superior esthetics and durability with remarkable gingival responses up to 24 months. A clinical study on the wear behavior of primary enamel against Zirconia crowns demonstrated the lowest wear rate of primary enamel. A retrospective study that evaluated the clinical success and parental satisfaction showed a considerable percentage (89%) of parents were highly satisfied by the crowns' size, color, and form.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NuSmile Zirconia crowns | Active comparator | Other: Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crownsPrefabricated pediatric Zirconia crowns offer an excellent alternative to full-coverage crowns when restoring deciduous teeth with a sizeable carious defect |
| BioFlx crowns | Experimental | Other: Restoration of Pulpotomized Primary Molars using BioFlx crownsThe 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 |
| Digital VITA ENAMIC crowns | Experimental | Other: 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. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crownsPrefabricated 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 | Other | NuSmile Zirconia crowns |
| Restoration of Pulpotomized Primary Molars using BioFlx crownsThe 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. | Other | BioFlx crowns |
| 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. | Other | Digital VITA ENAMIC crowns |
Primary outcome
Clinical success
Time frame: 12 months
aesthetics, functional and biological criteria of the restorations
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Pulpotomized Primary Molars
Not yet recruiting
Assessment of Clinical Success of Custom-Made Versus Prefabricated Zirconia Crowns in Pulpotomized Primary Molars
Primary Molar Tooth, Pulpotomies Primary Teeth
Not yet recruiting
3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.
Dental Caries
Recruiting
Bioceramic Putty Versus MTA in Pulpotomized Primary Teeth to be Covered With 3D Printed Resin Crowns Versus Stainless Steel Crown
Caries Active
Not yet recruiting
Clinical Performance and Antibacterial Effect of Alkasite Bioactive Material in Restoring Pulpotomized Primary Molars
Healthy Children
Active, not recruitingObservational study
Effectiveness of Premixed Bioactive Bioceramic MTA (Neo-Putty®) in Pulpotomies Primary Teeth
Pulpotomies on Primary Molars
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Attia, Ph.D contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration of Pulpotomized Primary Molars using NuSmile Zirconia crowns, Restoration of Pulpotomized Primary Molars using BioFlx crowns and Restoration of Pulpotomized Primary Molars using Digital VITA ENAMIC crowns (CAD/CAM blanks) in people with Pulpotomized Primary Molars, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Salamon,, Ph.D (+20 101 655 5055, maasalmon@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.