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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Ain shams university

    Cairo, Abbasya, 4576

Other trials in Egypt

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:

  1. Local anesthesia will be administered.
  2. Teeth will be isolated by a Rubber Dam.
  3. 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:

  1. 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.
  2. impression for the preparation is taken using putty and light poly vinyl siloxane material
  3. Light cured temporary filling will be placed in the cavity as temporisation.
  4. The impression will be sent to the lab and the patient is dismissed
  5. The preparation will be optically scanned in the lab and the restoration will be digitally designed using computer designing software.
  6. The restoration will be printed using 3D printer using microfilled hybrid composite material.
  7. 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:

  1. 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
  2. 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.
  3. . 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.
  4. 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.

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 groups in NCT04909827
Study groupRoleWhat they receive
group AExperimental3D printed microfilled hybrid composite Endocrowns
Receives: Procedure: 3D-printed endocrown
group BExperimentalprefabricated zirconia crowns
Receives: Procedure: Zirconia crown

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted2 Jun 2021
  2. Study start1 Sep 2021
  3. Primary completion28 Feb 2023
  4. Study completion28 Feb 2023

Resources

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)
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

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.

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