Dental CrownsNCT06581510
Custom-Made Zirconia Crowns and 3D-Printed Resin Crowns Versus Ready-Made Zirconia Crowns in Primary Molars
A study testing esthetic dental crowns in people with Dental Crowns, run by British University In Egypt at 2 sites in Egypt.
Trial summary
The main problem introduced in this study is the aggressive reduction needed for ready-made zirconia crowns to be passively fitted. In addition, its relatively expensive cost and wear of the opposing tooth structure. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crowns
- What is being tested?
- esthetic dental crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Feb 2024to 23 Feb 2026
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children within age range of 5-8 years old
- Upper and lower primary second molars
- Vital primary second molars
- Cooperative children Frankl scale 3 (positive) and 4 (definitely positive)
Who cannot join
- Radiographic radiolucency related to the furcation and periapical area or any evidence of root resorption
- Deep bite
- More than 2 walls lost due to caries
- Presence of parafunctional habits
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
The British university in Egypt
Cairo
Fatemah usama, 01098781655, fatemah.usama@bue.edu.eg
Sara Magdy, 01006786219, sara.abdelhakiem@bue.edu.eg
- Recruiting
The British university in Egypt
Cairo
Noha Kabil, Professor, +201005131500, noha.kabil@bue.edu.eg
Fatemah Osama
About this study
Official title: Custom-Made Zirconia Crowns and 3D Printed Resin Crowns Versus Ready-Made Zirconia Crowns in Primary Molars: A Randomized Controlled Trial
The main problem introduced in this study is the aggressive reduction needed for ready-made zirconia crowns to be passively fitted. In addition, its relatively expensive cost and wear of the opposing tooth structure. In this study, different crown materials will be introduced, such as customized zirconia crowns and novel 3D printed resin crowns who may offer better adaptability and gingival health and are relatively cost effective. The proposed study will help in increasing studies of different crown materials for primary teeth
Read the detailed description
According to AAPD, pulpally treated or deep carious primary teeth should be restored with full coverage crowns for protection of the remaining tooth structure and integrity of occlusion. Different crown materials and compositions have been introduced; however, each with their own drawbacks. Stainless steel crowns have remained the gold standard for restoring primary molars, with the advantages of minimal preparation needed and better adaptability of margins due to their burnishing ability. On the other hand, stainless steel crowns suffer from poor aesthetics and gingival health. The aesthetics of pre-veneered stainless-steel crowns improved but were significantly reduced when the veneered surface was chipped, which was a major drawback in the crown; in addition to their decreased strength and durability in comparison to stainless steel crowns. Strip crowns and polycarbonate crowns were also introduced; however, because of their weak bonding capacity, they have poor strength and an uncertain position in the posterior primary teeth. Due to the increase of aesthetic demand in pediatric dentistry, zirconia crowns have been introduced. Zirconia crowns present the highest aesthetics compared to different pediatric crowns and highest strength compared to all ceramic restorations. However, they need very deep subgingival preparation, poor adaptability because it can't be crimped due to poor burnishing ability and relatively expensive.
Recently, new advances in pediatric crowns have been introduced including computerized 3D printed resin or milled zirconia crowns. Those recent advances have promising results in aesthetics and strength in comparison to ready-made zirconia crowns. Ready-made zirconia crowns have been an exceptionally good biocompatible material. One of the main benefits of those crowns is their durability alongside an outstanding aesthetic appearance. Furthermore, because of their extremely polished surface, ready-made zirconia crowns have proved to have less plaque buildup when compared to other materials. However, because they are costly, need extensive sub-gingival tooth reduction, and cause wear of opposing tooth structure, there are several clinical restrictions and drawbacks.
New computer-aided design digital models serve as the foundation for three-dimensional (3D) printing technologies, which are sophisticated manufacturing techniques that generate customized 3D objects automatically. With applications in almost all fields of dentistry, three-dimensional printing fabricates excellent fitted, accurate, and biocompatible crowns that may overcome ready-made zirconia crowns.
On the other hand, currently the zirconia-based CAD/CAM system has the strongest fracture strength of any all-ceramic material and has continuously produced the most accurate, aesthetically pleasing replication of natural dentition.
They've been acknowledged by patients and dentists alike. The zirconia-based CAD/CAM system is recommended for crowns and bridges in natural teeth, implants, and telescopic dentures. Customized zirconia crowns could be an alternative to the drawbacks presented in ready-made zirconia crowns
- Conditions
- Dental Crowns
- Being tested
- esthetic dental crowns, control group
- Keywords
- pediatric esthetic crowns, posterior esthetic crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esthetic dental crownsProcedure or surgery
Minimal Preparation of esthetic dental crown
control groupProcedure or surgery
Nuu smile ready-made zirconia crown with its well-known reduction
| Study group | Role | What they receive |
|---|---|---|
| Custom-Made Zirconia crowns | Experimental | CAD/CAM zirconia crown customized for each patient Receives: Procedure: esthetic dental crowns |
| 3D Printed Resin Crowns | Experimental | Printed resin crowns customized for each patient Receives: Procedure: esthetic dental crowns |
| Ready-Made Zirconia Crowns | Experimental | Nuu smile ready made zirconia crown Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional, biological , and esthetic performance according to FDI clinical criteria
FDI World Dental Federation scores from 1-5 (highest score 1 and lowest score 5 )
Measured: 3,6,9 months
Measure amount of reduction done after preparation
Using superimposition technique
Measured: During procedure
Measure time taken during preparation
Stopwatch / timer from start of preparation till the end of preparation
Measured: During procedure
Measure amount of bleeding during preparation
Gravimetric method by weighing pre and post procedure gauze on scale
Measured: immediately after completion of the procedure (after reduction and cementation of dental crown)
Secondary outcomes (2)
Patient's satisfaction while restoring primary molars
Wong baker Faces scale ( 0 least indication no pain and 5 highest indicating pain)
Measured: During procedure
Measure cost-effectiveness of each crown material
Compare costs between different crown materials
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start25 Feb 2024
- Primary completion23 Feb 2026 (estimated)
- Study completion23 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental CrownsStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatema usama, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581510
- Sponsor's protocol ID
- 24-010
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.
PubMed 33772904Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.
PubMed 35270531Jain S, Sayed ME, Shetty M, Alqahtani SM, Al Wadei MHD, Gupta SG, Othman AAA, Alshehri AH, Alqarni H, Mobarki AH, Motlaq K, Bakmani HF, Zain AA, Hakami AJ, Sheayria MF. Physical and Mechanical Properties of 3D-Printed Provisional Crowns and Fixed Dental Prosthesis Resins Compared to CAD/CAM Milled and Conventional Provisional Resins: A Systematic Review and Meta-Analysis. Polymers (Basel). 2022 Jun 30;14(13):2691. doi: 10.3390/polym14132691.
PubMed 35808735Dewan H. Clinical Effectiveness of 3D-Milled and 3D-Printed Zirconia Prosthesis-A Systematic Review and Meta-Analysis. Biomimetics (Basel). 2023 Aug 27;8(5):394. doi: 10.3390/biomimetics8050394.
PubMed 37754145Sztyler K, Wiglusz RJ, Dobrzynski M. Review on Preformed Crowns in Pediatric Dentistry-The Composition and Application. Materials (Basel). 2022 Mar 11;15(6):2081. doi: 10.3390/ma15062081.
PubMed 35329535
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Custom-Made Zirconia Crowns and 3D Printed Resin Crowns Versus Ready-Made Zirconia Crowns in Primary Molars: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06581510
- Acronym / sponsor ID
- 24-010
- Conditions
- Dental Crowns
- Keywords
- pediatric esthetic crowns, posterior esthetic crowns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 23 Feb 2026 (estimated)
- Study completion
- 23 Feb 2026 (estimated)
- First posted
- 3 Sep 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.
The main problem introduced in this study is the aggressive reduction needed for ready-made zirconia crowns to be passively fitted. In addition, its relatively expensive cost and wear of the opposing tooth structure. In this study, different crown materials will be introduced, such as customized zirconia crowns and novel 3D printed resin crowns who may offer better adaptability and gingival health and are relatively cost effective. The proposed study will help in increasing studies of different crown materials for primary teeth
Detailed description
According to AAPD, pulpally treated or deep carious primary teeth should be restored with full coverage crowns for protection of the remaining tooth structure and integrity of occlusion. Different crown materials and compositions have been introduced; however, each with their own drawbacks. Stainless steel crowns have remained the gold standard for restoring primary molars, with the advantages of minimal preparation needed and better adaptability of margins due to their burnishing ability. On the other hand, stainless steel crowns suffer from poor aesthetics and gingival health. The aesthetics of pre-veneered stainless-steel crowns improved but were significantly reduced when the veneered surface was chipped, which was a major drawback in the crown; in addition to their decreased strength and durability in comparison to stainless steel crowns. Strip crowns and polycarbonate crowns were also introduced; however, because of their weak bonding capacity, they have poor strength and an uncertain position in the posterior primary teeth. Due to the increase of aesthetic demand in pediatric dentistry, zirconia crowns have been introduced. Zirconia crowns present the highest aesthetics compared to different pediatric crowns and highest strength compared to all ceramic restorations. However, they need very deep subgingival preparation, poor adaptability because it can't be crimped due to poor burnishing ability and relatively expensive.
Recently, new advances in pediatric crowns have been introduced including computerized 3D printed resin or milled zirconia crowns. Those recent advances have promising results in aesthetics and strength in comparison to ready-made zirconia crowns. Ready-made zirconia crowns have been an exceptionally good biocompatible material. One of the main benefits of those crowns is their durability alongside an outstanding aesthetic appearance. Furthermore, because of their extremely polished surface, ready-made zirconia crowns have proved to have less plaque buildup when compared to other materials. However, because they are costly, need extensive sub-gingival tooth reduction, and cause wear of opposing tooth structure, there are several clinical restrictions and drawbacks.
New computer-aided design digital models serve as the foundation for three-dimensional (3D) printing technologies, which are sophisticated manufacturing techniques that generate customized 3D objects automatically. With applications in almost all fields of dentistry, three-dimensional printing fabricates excellent fitted, accurate, and biocompatible crowns that may overcome ready-made zirconia crowns.
On the other hand, currently the zirconia-based CAD/CAM system has the strongest fracture strength of any all-ceramic material and has continuously produced the most accurate, aesthetically pleasing replication of natural dentition.
They've been acknowledged by patients and dentists alike. The zirconia-based CAD/CAM system is recommended for crowns and bridges in natural teeth, implants, and telescopic dentures. Customized zirconia crowns could be an alternative to the drawbacks presented in ready-made zirconia crowns
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Custom-Made Zirconia crowns | Experimental | Procedure: esthetic dental crownsCAD/CAM zirconia crown customized for each patient |
| 3D Printed Resin Crowns | Experimental | Procedure: esthetic dental crownsPrinted resin crowns customized for each patient |
| Ready-Made Zirconia Crowns | Experimental | Procedure: control groupNuu smile ready made zirconia crown |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children within age range of 5-8 years old
- Upper and lower primary second molars
- Vital primary second molars
- Cooperative children Frankl scale 3 (positive) and 4 (definitely positive)
Key exclusion criteria (4 listed)
- Radiographic radiolucency related to the furcation and periapical area or any evidence of root resorption
- Deep bite
- More than 2 walls lost due to caries
- Presence of parafunctional habits
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 |
|---|---|---|
| esthetic dental crownsMinimal Preparation of esthetic dental crown | Procedure or surgery | 3D Printed Resin Crowns, Custom-Made Zirconia crowns |
| control groupNuu smile ready-made zirconia crown with its well-known reduction | Procedure or surgery | Ready-Made Zirconia Crowns |
Primary outcome
Functional, biological , and esthetic performance according to FDI clinical criteria
Time frame: 3,6,9 months
FDI World Dental Federation scores from 1-5 (highest score 1 and lowest score 5 )
Measure amount of reduction done after preparation
Time frame: During procedure
Using superimposition technique
Measure time taken during preparation
Time frame: During procedure
Stopwatch / timer from start of preparation till the end of preparation
Measure amount of bleeding during preparation
Time frame: immediately after completion of the procedure (after reduction and cementation of dental crown)
Gravimetric method by weighing pre and post procedure gauze on scale
2 secondary outcomes
Patient's satisfaction while restoring primary molars
Time frame: During procedure
Measure cost-effectiveness of each crown material
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 33772904Alrashdi M, Ardoin J, Liu JA. Zirconia crowns for children: A systematic review. Int J Paediatr Dent. 2022 Jan;32(1):66-81. doi: 10.1111/ipd.12793. Epub 2021 Apr 25.
- Background: PubMed 35270531Alzanbaqi SD, Alogaiel RM, Alasmari MA, Al Essa AM, Khogeer LN, Alanazi BS, Hawsah ES, Shaikh AM, Ibrahim MS. Zirconia Crowns for Primary Teeth: A Systematic Review and Meta-Analyses. Int J Environ Res Public Health. 2022 Feb 28;19(5):2838. doi: 10.3390/ijerph19052838.
- Background: PubMed 35808735Jain S, Sayed ME, Shetty M, Alqahtani SM, Al Wadei MHD, Gupta SG, Othman AAA, Alshehri AH, Alqarni H, Mobarki AH, Motlaq K, Bakmani HF, Zain AA, Hakami AJ, Sheayria MF. Physical and Mechanical Properties of 3D-Printed Provisional Crowns and Fixed Dental Prosthesis Resins Compared to CAD/CAM Milled and Conventional Provisional Resins: A Systematic Review and Meta-Analysis. Polymers (Basel). 2022 Jun 30;14(13):2691. doi: 10.3390/polym14132691.
- Background: PubMed 37754145Dewan H. Clinical Effectiveness of 3D-Milled and 3D-Printed Zirconia Prosthesis-A Systematic Review and Meta-Analysis. Biomimetics (Basel). 2023 Aug 27;8(5):394. doi: 10.3390/biomimetics8050394.
- Background: PubMed 35329535Sztyler K, Wiglusz RJ, Dobrzynski M. Review on Preformed Crowns in Pediatric Dentistry-The Composition and Application. Materials (Basel). 2022 Mar 11;15(6):2081. doi: 10.3390/ma15062081.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esthetic dental crowns in people with Dental Crowns, run by British University In Egypt at 2 sites 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 4 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 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Fatemah usama (+201098781655, fatemah.usama@bue.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional, biological , and esthetic performance according to FDI clinical criteria (time frame: 3,6,9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06581510, which also lists 5 linked publications.
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 3 Sep 2024.