PulpotomyPhase 4NCT04909827
3D-printed Endocrowns Versus Prefabricated Zirconia Crowns in Pulpally-treated Primary Molars
A Phase 4 study testing 3D-printed endocrown and Zirconia crown in people with Pulpotomy and Tooth Restoration, run by Ain Shams University at 1 site in Egypt.
Trial summary
Aim of the study : to compare between 3D printed microfilled hybrid composite endocrowns and prefabricated zirconia crowns for restoring pulpally treated primary molars regarding the following aspects: In Vivo aspects Patient satisfaction *The esthetic, functional and biological performance according to FDI clinical… Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy, Tooth Restoration
- What is being tested?
- 3D-printed endocrown and Zirconia crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 28 Feb 2023
- Phase
- Phase 4
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
- The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.
Who cannot join
- Children who are uncooperative needing sedatin or general anasthesia.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- Teeth of poor prognosis due to th e presence of an abscess or a sinus, mobility, advanced bone or root resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D-printed Endocrowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars ; In-Vivo and In-Vitro Study
Aim of the study :
to compare between 3D printed microfilled hybrid composite endocrowns and prefabricated zirconia crowns for restoring pulpally treated primary molars regarding the following aspects: In Vivo aspects Patient satisfaction
Read more
*The esthetic, functional and biological performance according to FDI clinical criteria. At 3, 6 and 12 months
In Vitro aspects:
- Marginal gap.
- Fracture resistance.
Study methodology:
This study is a combined randomized clinical trial and in vitro study .The study will be conducted at the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry,
Ain Shams University as follows:
In vivo comparison of the clinical performance of 3D printed Endocrowns versus prefabricated zirconia crowns regarding esthetic, functional and biological performance according to FDI clinical criteria. In vitro evaluation of the marginal gap and fracture resistance of both types of restorations.
Read the detailed description
Study Procedure:
In-vivo Phase:
Study Population:
A total of thirty primary mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. Randomization The molars will be assigned to one of the 2 groups using a generated computer list Allocation The molars will be allocated to the groups via a third party not involved with the study They will have the generated list and inform the allocation accordingly Blinding Is not possible due to the obvious difference between the 2 Pulpotomy procedure for both groups:
- Local anesthesia will be administered.
- Teeth will be isolated by a Rubber Dam.
- Teeth will undergo pulpotomy procedure' as follows:
Caries will be removed using a large size 4 round bur, mounted onto a high speed hand piece with constant coolant. All access cavity walls are to be flared to allow complete exposure of the pulp chamber, and easy undisturbed access to the canals, followed by removal of all the soft pulpal tissue tags by a sharp spoon shaped excavator. Bleeding will be controlled using moist cotton pellet with gentle pressure. Formocresol will be applied through a cotton pellet for 5 mins, for fixation. The pulp chamber will be filled with reinforced zinc oxide and eugenol ( that will be mixed according to manufacturer s instructions. A 0.5 mm layer of Resin modified glass ionomer is then applied to the cavity floor and light cured for 40 secs, to isolate the zinc oxide eugenol paste, and block unwanted undercuts Analgesics will be prescribed to the patient to be taken when needed
Intervention :group A:
- The cavities will be prepared so as to receive endocrowns: Occlusal preparation: achieved by drilling, 2mm depth grooves using diamond stone as guides for reduction of the occlusal surface. axial preparation: using a 7 degree taper diamond stone, eliminating undercuts in the access cavity.
- impression for the preparation is taken using putty and light poly vinyl siloxane material
- Light cured temporary filling will be placed in the cavity as temporisation.
- The impression will be sent to the lab and the patient is dismissed
- The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.
- The restoration will be printed using 3D printer using microfilled hybrid composite material.
- During the second visit the temporary is removed the restoration is cemented by self adhesive resin after etching and bonding the cavity.
Control Group B:
- Crown reduction: reduction will be performed on the occlusal surface disregarding the occlusal anatomy using a flame stone or a wheel stone, to perform occlusal clearance. Then reduction will be performed on the mesial, distal, buccal and lingual surfaces of the tooth to compensate for the thickness of the zirconia crowns. Reduction will first be performed using fine needle stone to free the contact from the adjacent teeth then followed by reduction of the other surfaces using a diamond stone. Roundation of the line angles will be performed
- Zirconia crowns that match the size of the tooth will be selected putting into consideration that no undercuts should be present to avoid crown fracture.
- . After checking the size of the crowns, it will be removed, drie d and cemented on the tooth using (3M™ ESPE™ KETAC™ CEM) that will be mixed according to manufacturer's instructions.
- Pressure will be applied on the crown, and any excess cement will be removed after it hardens. All children and parents will be give n strict oral hygiene instructions and dietary instructions Teeth not included in the study will be scheduled for dental treatment in the Department of Pediatric Dentistry, Faculty of Dentistry, Ain Shams University. Outcome measurement
Esthetic functional biological criteria will be evaluated in the following order:
After cementation evaluation: patients will be evaluated according to FDI criteria as previously mentioned,.
In Vitro phase:
All soft tissue debris will be removed by a hand scaler and teeth will be disinfect ed, and then stored in distilled water at 4 degrees Celsius until the start of the study.
The molars will undergo pulpotomy procedures and filled as previously described. The molars will be randomly divided into two groups Group A: Will receive 3D printed Endocrowns Group B: Will receive prefabricated zirconia crowns The specimens will be embedded perpendicularly in Polyvinyl chloride ( cubes with the occlusal surface parallel to the ground using acrylic resin extending 2mm b elow the cemento enamel junction. The following will be measured: Marginal gap Precementation measurements of the cervical vertical marginal discrepancies will be performed before cementation. For each specimen, four stereomicrographs will be captured by a stereomicroscope (Wild 400, Switzerland) at a 32× magnification. Images will then be transferred to the computer software for image analysis
Fracture Resistance:
An axial loading condition through the functional cusp will be defined in the mechanical failure description. Failure to fracture strength will be tested with a universal testing machine at a 0.5 mm/sec crosshead speed. Application of a round end vertical loading tip on the occlusal third of a specimen fixed into a loading apparatus as functional loading simulation.
Data Management:
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as co nfidential information that should never be revealed at all times. This file will remain with the investigator during the study.
Statistical Analysis:
All data will be tabulated, summarized and statistically analyzed using software SPSS (Statistical Packages for Social Sciences. 3 and 6 months evaluation: evaluation of the previous criteria.
- Conditions
- Pulpotomy, Tooth Restoration
- Being tested
- 3D-printed endocrown, Zirconia crown
- Keywords
- 3D-printing, Endocrown, zirconia crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed endocrownProcedure or surgery
pulpotomy and restoration with 3D-printed microfilled hybrid composite endocrown
Zirconia crownProcedure or surgery
pulpotomy and restoration with prefabricated zirconia crown
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | 3D printed microfilled hybrid composite Endocrowns Receives: Procedure: 3D-printed endocrown |
| group B | Experimental | prefabricated zirconia crowns Receives: Procedure: Zirconia crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical performance
Federation Dentaire international clinical assessment scale. Minimum value is 1 and highest value is 11. Higher values mean worst outcome.
Measured: 6 months
Secondary outcomes (1)
patient satisfaction
A structured patient satisfaction questionnaire with a 3 points likert scale question.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Sep 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpotomyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of thirty primary mandibular molars in healthy subjects will be selected. The molars will be randomly assigned equally into two treatment groups 1. Group A: 3D printed microfilled hybrid composite Endocrowns 2. Group B: pr efabricated zirconia crowns Pulpotomy
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Hussein, Ain Shams University
- Investigators
- Mariem O Wassel, PhD, Study director, Ainshams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909827
- Sponsor's protocol ID
- PED 20-6D
- Status last verified
- Jul 2023
- First submitted
- 26 May 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbas LH, Wassel MO, Hassan IT, El-Dimeery AG, Elghazawy RK. 3D printed endocrowns versus prefabricated zirconia crowns for pulpotomized primary molars: A randomized controlled trial. J Dent. 2025 Feb;153:105556. doi: 10.1016/j.jdent.2025.105556. Epub 2025 Jan 6.
PubMed 39778737
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-printed Endocrowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars ; In-Vivo and In-Vitro Study
- ClinicalTrials.gov ID
- NCT04909827
- Acronym / sponsor ID
- PED 20-6D
- Conditions
- Pulpotomy, Tooth Restoration
- Keywords
- 3D-printing, Endocrown, zirconia crown
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 2 Jun 2021 (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.
Aim of the study :
to compare between 3D printed microfilled hybrid composite endocrowns and prefabricated zirconia crowns for restoring pulpally treated primary molars regarding the following aspects: In Vivo aspects Patient satisfaction
*The esthetic, functional and biological performance according to FDI clinical criteria. At 3, 6 and 12 months
In Vitro aspects:
- Marginal gap.
- Fracture resistance.
Study methodology:
This study is a combined randomized clinical trial and in vitro study .The study will be conducted at the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry,
Ain Shams University as follows:
In vivo comparison of the clinical performance of 3D printed Endocrowns versus prefabricated zirconia crowns regarding esthetic, functional and biological performance according to FDI clinical criteria. In vitro evaluation of the marginal gap and fracture resistance of both types of restorations.
Detailed description
Study Procedure:
In-vivo Phase:
Study Population:
A total of thirty primary mandibular molars in healthy subjects will be selected from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University. Randomization The molars will be assigned to one of the 2 groups using a generated computer list Allocation The molars will be allocated to the groups via a third party not involved with the study They will have the generated list and inform the allocation accordingly Blinding Is not possible due to the obvious difference between the 2 Pulpotomy procedure for both groups:
- Local anesthesia will be administered.
- Teeth will be isolated by a Rubber Dam.
- Teeth will undergo pulpotomy procedure' as follows:
Caries will be removed using a large size 4 round bur, mounted onto a high speed hand piece with constant coolant. All access cavity walls are to be flared to allow complete exposure of the pulp chamber, and easy undisturbed access to the canals, followed by removal of all the soft pulpal tissue tags by a sharp spoon shaped excavator. Bleeding will be controlled using moist cotton pellet with gentle pressure. Formocresol will be applied through a cotton pellet for 5 mins, for fixation. The pulp chamber will be filled with reinforced zinc oxide and eugenol ( that will be mixed according to manufacturer s instructions. A 0.5 mm layer of Resin modified glass ionomer is then applied to the cavity floor and light cured for 40 secs, to isolate the zinc oxide eugenol paste, and block unwanted undercuts Analgesics will be prescribed to the patient to be taken when needed
Intervention :group A:
- The cavities will be prepared so as to receive endocrowns: Occlusal preparation: achieved by drilling, 2mm depth grooves using diamond stone as guides for reduction of the occlusal surface. axial preparation: using a 7 degree taper diamond stone, eliminating undercuts in the access cavity.
- impression for the preparation is taken using putty and light poly vinyl siloxane material
- Light cured temporary filling will be placed in the cavity as temporisation.
- The impression will be sent to the lab and the patient is dismissed
- The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.
- The restoration will be printed using 3D printer using microfilled hybrid composite material.
- During the second visit the temporary is removed the restoration is cemented by self adhesive resin after etching and bonding the cavity.
Control Group B:
- Crown reduction: reduction will be performed on the occlusal surface disregarding the occlusal anatomy using a flame stone or a wheel stone, to perform occlusal clearance. Then reduction will be performed on the mesial, distal, buccal and lingual surfaces of the tooth to compensate for the thickness of the zirconia crowns. Reduction will first be performed using fine needle stone to free the contact from the adjacent teeth then followed by reduction of the other surfaces using a diamond stone. Roundation of the line angles will be performed
- Zirconia crowns that match the size of the tooth will be selected putting into consideration that no undercuts should be present to avoid crown fracture.
- . After checking the size of the crowns, it will be removed, drie d and cemented on the tooth using (3M™ ESPE™ KETAC™ CEM) that will be mixed according to manufacturer's instructions.
- Pressure will be applied on the crown, and any excess cement will be removed after it hardens. All children and parents will be give n strict oral hygiene instructions and dietary instructions Teeth not included in the study will be scheduled for dental treatment in the Department of Pediatric Dentistry, Faculty of Dentistry, Ain Shams University. Outcome measurement
Esthetic functional biological criteria will be evaluated in the following order:
After cementation evaluation: patients will be evaluated according to FDI criteria as previously mentioned,.
In Vitro phase:
All soft tissue debris will be removed by a hand scaler and teeth will be disinfect ed, and then stored in distilled water at 4 degrees Celsius until the start of the study.
The molars will undergo pulpotomy procedures and filled as previously described. The molars will be randomly divided into two groups Group A: Will receive 3D printed Endocrowns Group B: Will receive prefabricated zirconia crowns The specimens will be embedded perpendicularly in Polyvinyl chloride ( cubes with the occlusal surface parallel to the ground using acrylic resin extending 2mm b elow the cemento enamel junction. The following will be measured: Marginal gap Precementation measurements of the cervical vertical marginal discrepancies will be performed before cementation. For each specimen, four stereomicrographs will be captured by a stereomicroscope (Wild 400, Switzerland) at a 32× magnification. Images will then be transferred to the computer software for image analysis
Fracture Resistance:
An axial loading condition through the functional cusp will be defined in the mechanical failure description. Failure to fracture strength will be tested with a universal testing machine at a 0.5 mm/sec crosshead speed. Application of a round end vertical loading tip on the occlusal third of a specimen fixed into a loading apparatus as functional loading simulation.
Data Management:
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as co nfidential information that should never be revealed at all times. This file will remain with the investigator during the study.
Statistical Analysis:
All data will be tabulated, summarized and statistically analyzed using software SPSS (Statistical Packages for Social Sciences. 3 and 6 months evaluation: evaluation of the previous criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of thirty primary mandibular molars in healthy subjects will be selected. The molars will be randomly assigned equally into two treatment groups 1. Group A: 3D printed microfilled hybrid composite Endocrowns 2. Group B: pr efabricated zirconia crowns Pulpotomy
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: 3D-printed endocrown3D printed microfilled hybrid composite Endocrowns |
| group B | Experimental | Procedure: Zirconia crownprefabricated zirconia crowns |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
- The anticipated exfoliation date of the selected primary teeth has to be more than 12 months from the date of the study start.
Key exclusion criteria (3 listed)
- Children who are uncooperative needing sedatin or general anasthesia.
- Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
- Teeth of poor prognosis due to th e presence of an abscess or a sinus, mobility, advanced bone or root resorption.
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 endocrownpulpotomy and restoration with 3D-printed microfilled hybrid composite endocrown | Procedure or surgery | group A |
| Zirconia crownpulpotomy and restoration with prefabricated zirconia crown | Procedure or surgery | group B |
Primary outcome
clinical performance
Time frame: 6 months
Federation Dentaire international clinical assessment scale. Minimum value is 1 and highest value is 11. Higher values mean worst outcome.
1 secondary outcome
patient satisfaction
Time frame: 6 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 20 Jul 2023.
- Derived from this study: PubMed 39778737Abbas LH, Wassel MO, Hassan IT, El-Dimeery AG, Elghazawy RK. 3D printed endocrowns versus prefabricated zirconia crowns for pulpotomized primary molars: A randomized controlled trial. J Dent. 2025 Feb;153:105556. doi: 10.1016/j.jdent.2025.105556. Epub 2025 Jan 6.
- 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.
Mariem O Wassel, PhD 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 Phase 4 study testing 3D-printed endocrown and Zirconia crown in people with Pulpotomy and Tooth Restoration, 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 2 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 20 Jul 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
clinical performance (time frame: 6 months). 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 NCT04909827, which also lists 1 linked publication.
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 20 Jul 2023.