3D Printed CrownsNCT06047925
3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars
A study testing 3D printed crown and stanless steel crown in people with 3D Printed Crowns, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- 3D Printed Crowns
- What is being tested?
- 3D printed crown and stanless steel crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 29 Aug 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 10 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children included in the study should conform to the following criteria:
- Badly broken-down endodontically treated first permanent molar
- First permanent molar with extensive multi-surface caries.
- First permanent molar with structural developmental defects such as hypoplasia, Molar-Incisor Hypomineralization (MIH), Amelogenesis Imperfecta, and Dentinogenesis Imperfecta
Who cannot join
- Children who are uncooperative needing sedation or general anesthesia.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- Molars of poor prognosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars (Randomized Controlled Clinical Trial)
The study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars
Read the detailed description
A total of Forty permanent first mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic.
The molars will be randomly assigned equally into two treatment groups group A 3D-printed crowns \& group B prefabricated SSCs, removal of caries with a high-speed handpiece then removal of the remaining carious lesion with excavator then glass ionomer restoration will be placed, preparation of SSCs crowns will be done in Group A by reduction of occlusal surface by about 1.5 mm, Proximally, tooth reduction is made through the mesial and distal contact areas, then roundation of line angles. Proper size of crown will be selected. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. In group B reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance. Reduction will be performed on the mesial, distal, buccal, and lingual surfaces of the tooth Then roundation of the line angles will be performed. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software. The crown will be printed using 3D printer using hybrid resin material. Crown will be checked for proper fit and cemented to the tooth by self-etch adhesive.
- Conditions
- 3D Printed Crowns
- Being tested
- 3D printed crown, stanless steel crown
- Keywords
- 3D printed crowns- Stainless steel crowns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed crownProcedure or surgery
Reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance by 1 mm. Reduction will be performed by 1 mm on the mesial, distal, buccal and lingual surfaces of the tooth. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. Temporary crown will be placed above the preparation as temporisation.The impression will be sent to the lab .The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.The crown will be printed using 3D printer using hybrid resin(micro-filled hybrid material) material.The 3d printed crown is cemented with resin cement.
stanless steel crownProcedure or surgery
The occlusal surface of the tooth should be reduced by about 1.5 mm, maintaining its occlusal contour or until the tooth is out of occlusion with adequate room to fit a crown.Proximally, tooth reduction will be made through the mesial and distal contact areas, then roundation of line angles to avoid the creation of ledges or steps.The crown selection will be done by trial and error or by measuring the mesiodistal dimension of the tooth space with dividers. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | First permanant molar will be prepared to receive 3D printed crown Receives: Procedure: 3D printed crown |
| group B | Active comparator | First permanant molar will be prepared to receive SSC Receives: Procedure: stanless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars
Evaluation of clinical performance of both crowns regarding gingival health (gingival \& plaque index) and Fracture, retention, marginal discoloration and surface texture according to the modified United states Public Health Service (USPHS) criteria. 3,6-12 and 18 months.
Measured: 3,6,12 and 18 months
Secondary outcomes (1)
Patient and parent satisfaction.
Parental and patient satisfaction will be assessed during the delivery session to determine their satisfaction level with 5-point Likert scale where 1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied. Child's perception regarding their esthetics with crowns will be also considered in this study. Children will be asked to rank the crowns based on "Smiley Face Likert Scale."
Measured: Immediately ,3,6,12&18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jun 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 3D Printed CrownsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- one experimental group and one active comparator group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Bassam Mohamed Ahmed, Ain Shams University
- Investigators
- Nagwa khattab, BDS,MSc,MD, Study director, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047925
- Sponsor's protocol ID
- FDASU-RECID022321
- Status last verified
- Nov 2024
- First submitted
- 15 Sep 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-printed Crowns Versus Prefabricated Stainless-Steel Crowns for Intermediate Restoration of Compromised First Permanent Molars (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06047925
- Acronym / sponsor ID
- FDASU-RECID022321
- Conditions
- 3D Printed Crowns
- Keywords
- 3D printed crowns- Stainless steel crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 21 Sep 2023 (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 study will evaluate the clinical performance and both patient and parent satisfaction of 3d printed crowns versus prefabricated Stainless-steel crowns (SSCs) in compromised first permanent molars
Detailed description
A total of Forty permanent first mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic.
The molars will be randomly assigned equally into two treatment groups group A 3D-printed crowns \& group B prefabricated SSCs, removal of caries with a high-speed handpiece then removal of the remaining carious lesion with excavator then glass ionomer restoration will be placed, preparation of SSCs crowns will be done in Group A by reduction of occlusal surface by about 1.5 mm, Proximally, tooth reduction is made through the mesial and distal contact areas, then roundation of line angles. Proper size of crown will be selected. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. In group B reduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance. Reduction will be performed on the mesial, distal, buccal, and lingual surfaces of the tooth Then roundation of the line angles will be performed. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software. The crown will be printed using 3D printer using hybrid resin material. Crown will be checked for proper fit and cemented to the tooth by self-etch adhesive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one experimental group and one active comparator group
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: 3D printed crownFirst permanant molar will be prepared to receive 3D printed crown |
| group B | Active comparator | Procedure: stanless steel crownFirst permanant molar will be prepared to receive SSC |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children included in the study should conform to the following criteria:
Key exclusion criteria (3 listed)
- Children who are uncooperative needing sedation or general anesthesia.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- Molars of poor prognosis
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 |
|---|---|---|
| 3D printed crownReduction will be performed on the occlusal surface using a flame stone or a wheel stone, to perform occlusal clearance by 1 mm. Reduction will be performed by 1 mm on the mesial, distal, buccal and lingual surfaces of the tooth. Impression for the preparation will be taken using putty and light poly vinyl siloxane material. Temporary crown will be placed above the preparation as temporisation.The impression will be sent to the lab .The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.The crown will be printed using 3D printer using hybrid resin(micro-filled hybrid material) material.The 3d printed crown is cemented with resin cement. | Procedure or surgery | group A |
| stanless steel crownThe occlusal surface of the tooth should be reduced by about 1.5 mm, maintaining its occlusal contour or until the tooth is out of occlusion with adequate room to fit a crown.Proximally, tooth reduction will be made through the mesial and distal contact areas, then roundation of line angles to avoid the creation of ledges or steps.The crown selection will be done by trial and error or by measuring the mesiodistal dimension of the tooth space with dividers. It can also be helpful to measure the dimension of the contralateral tooth. A correctly fitting crown should snap or click at try in. | Procedure or surgery | group B |
Primary outcome
The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars
Time frame: 3,6,12 and 18 months
Evaluation of clinical performance of both crowns regarding gingival health (gingival \& plaque index) and Fracture, retention, marginal discoloration and surface texture according to the modified United states Public Health Service (USPHS) criteria. 3,6-12 and 18 months.
1 secondary outcome
Patient and parent satisfaction.
Time frame: Immediately ,3,6,12&18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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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.
Nagwa khattab, BDS,MSc,MD study director
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed crown and stanless steel crown in people with 3D Printed Crowns, run by Ain Shams University 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical performance of 3d printed crowns versus prefabricated SSCs in compromised first permanent molars (time frame: 3,6,12 and 18 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 17 Jul 2026.