Dental Caries in ChildrenNCT06068244
3D-printed Crowns Versus Zirconia Crowns for Primary Molars
A study testing 3D printed crowns and Zirconia crowns in people with Dental Caries in Children, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the present study is to compare between 3D-printed crowns and prefabricated zirconia crowns for restoring pulpally-treated primary molars regarding the following aspects: 1. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- 3D printed crowns and Zirconia crowns
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Nov 2024
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children included in the study should stratify to the following criteria:
- Age range of children from 4 -7 years.
- Having at least one vital primary molar with deep carious lesion indicated for pulpotomy or pulpectomy.
- The expected exfoliation date of the selected primary teeth must be more than 12 months from the start date of the study.
Who cannot join
- a) Uncooperative children who needs sedation or general anesthesia. b) Children with physical, intellectual disability or medical conditions that may complicate treatment.
- Teeth with poor prognosis due to the presence of an abscess or a sinus, mobility or advanced bone resorption.
- Presence of internal or external root resorption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D-Printed Crowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars; Randomized Clinical Trial and In-Vitro Study
The aim of the present study is to compare between 3D-printed crowns and prefabricated zirconia crowns for restoring pulpally-treated primary molars regarding the following aspects:
- In vivo: Evaluate the clinical outcome of 3D printed crowns in comparison to prefabricated zirconia crowns in pulpally-treated primary molars as well as parent satisfaction.
- In vitro:
Comparative analysis of fracture resistance and marginal gap of 3D printed crowns and prefabricated zirconia crowns
Read the detailed description
in vitro part :
All selected primary molars should fulfill the following criteria:
- Freshly extracted molars with at least three sound walls.
- Retain at least one third of their roots Teeth preparation All soft tissue debris will be removed with a hand scaler and teeth will be disinfected, and then stored in distilled water at 4 degrees Celsius until the start of the study.
Pulpotomy procedures will be performed to the extracted molars and the molars will be filled. Then, they will be randomly allocated into two groups.
Group 1: Will receive 3D-printed crowns Group 2: Will receive prefabricated zirconia crowns The specimens will be embedded perpendicularly in Polyvinyl chloride (PVC) cubes with the occlusal surface parallel to the ground using acrylic resin extending 2mm below the cementoenamel junction.
Evaluations: teeth in both groups will be evaluated for the following:
- Marginal gap: Precementation measurements of the cervical vertical marginal discrepancies will be performed before cementation., Four optical images for each specimen will be captured using 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 (LLOYD 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.
in vivo part : Teeth will be polished using a polishing paste and brush, and dried before being examined.
A dental mirror will be used for clinical examination under light emitting diode (LED) illumination to confirm the fulfillment of the inclusion criteria of the patient's selection.
- The molars will be randomly allocated into two equal treatment groups 23/each):
- Group 1: 3D-printed crowns
- Group 2: prefabricated zirconia crowns Pulpotomy procedure for both groups: <!-- -->
- Local anesthesia will be administered.
- Teeth will undergo pulpotomy procedure' as follows:
- Caries removal will be done using a large size 4 round bur, mounted onto a high-speed hand piece with constant coolant.
- All access cavity walls will 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 control will be done using moist cotton pellet with gentle pressure.
- Formocresol will be applied using a cotton pellet for 3-5 mins, for fixation.
- The pulp chamber will be filled with re-inforced zinc oxide and eugenol that will be mixed according to manufacturer's instructions.
- Analgesics will be prescribed to the patient to be taken when needed.
Intervention Group 1:
- Crown reduction: The teeth will be prepared using taper diamond bur with round end for buccal, lingual, mesial, and distal wall for 0.8- 1 mm, producing a chamfer margin circumferentially, and then, reduction of the occlusal surface will be done using a round wheel to produce occlusal clearance of 1.5 mm.
- Impression for the preparation will be taken using putty and light poly vinyl siloxane material.
- The impression will be sent to the lab and the patient will be dismissed.
- The preparation will be optically scanned in the lab and the crown will be digitally designed using computer designing software.
- The crown will be printed using 3D printer.
- The 3D printed crown will be cemented in the 2nd visit.
Control: Group 2:
- Crown reduction:
- In order to compensate for the thickness of zirconia crown, reduction will be performed on the mesial, distal, buccal and lingual surfaces of the tooth for 0.7-1.75mm. Reduction will be performed using fine needle stone in the beginning to free the contact from the adjacent teeth then followed by reduction of the other surfaces using a diamond stone.
- Reduction of the occlusal surface will be performed using a flame stone or wheel stone to produce occlusal clearance of 1.5- 2 mm.
- All line angles will be checked to remove any sharp line angles.
- Selection of the matching size from zirconia crowns will be made taking into consideration that the preparation must be free from any undercuts to avoid crown fracture.
- After checking the selected size of the crowns, it will be removed, dried and cemented to the tooth using resin cement.
Method of evaluation:
After cementation , at baseline ,3rd ,6th and 12th months evaluation of the crowns will be performed clinically using the modified U.S. Public Health Service criteria for retention, marginal integrity and gingival health for both groups. Also, parental satisfaction will be evaluated at end of the study using 5-point likert scale.
- Conditions
- Dental Caries in Children
- Being tested
- 3D printed crowns, Zirconia crowns
- Keywords
- "zirconia crowns", "pulpotomy", "3 dimension printed crowns"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed crownsOther
3D printed crowns
Zirconia crownsOther
Nu smile zirconia crowns
| Study group | Role | What they receive |
|---|---|---|
| 3D printed crowns | Experimental | Participants received 3D printed resin crowns Receives: Other: 3D printed crowns |
| Zirconia crowns | Active comparator | Participants received ready made zirconia crowns Receives: Other: Zirconia crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival health (gingival index)
Gingival index and plaque index
A gingival index, based on the Loe and Silness scoring criteria (1963). It will be measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each tooth. Scoring as followed:
0 = Normal (Absence of inflammation)
- = Mild gingivitis (slight change in color, slight edema. No bleeding on probing)
- = Moderate gingivitis (redness, edema and glazing. Bleeding on probing)
- = Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding)
- Gingival index and plaque index.
Measured: 1 year follow up for vivo part only
plaque index
Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically.
PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically.
PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental
Measured: 1year follow up
Marginal integrity
by visual inspection and explorer Alfa: Explorer does not catch or has one way catch when drawn across the restoration/tooth interface.
Bravo: Explorer falls into crevice when drawn across the restoration/tooth interface, Dentin is not exposed; clinically acceptable.
Charlie: Dentin or base is exposed along the margin; clinically unacceptable.
Measured: 1yeat follow up
crown retention
Alpha: Bonded Bravo: Debonded Charlie: Lost
Measured: one year follow up
In vitro marginal gap
micrometers
Measured: Immediately after samples preparation
in vitro fracture resistance
newton
Measured: Immediately after samples preparation
Secondary outcomes (1)
parent satisfaction
5-point likert scale.1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied.
Measured: immediately after cementation of crowns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esaad El Nagar, Ain Shams University
- Investigators
- Geham Gaber allam, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068244
- Sponsor's protocol ID
- PED23-1D
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamrah MH, Mokhtari S, Hosseini Z, Khosrozadeh M, Hosseini S, Ghafary ES, Hamrah MH, Narges Tavana. Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. Int J Dent. 2021 Jul 5;2021:7877728. doi: 10.1155/2021/7877728. eCollection 2021.
PubMed 34285695Al-Halabi MN, Bshara N, Nassar JA, Comisi JC, Rizk CK. Clinical Performance of Two Types of Primary Molar Indirect Crowns Fabricated by 3D Printer and CAD/CAM for Rehabilitation of Large Carious Primary Molars. Eur J Dent. 2021 Jul;15(3):463-468. doi: 10.1055/s-0040-1721905. Epub 2021 Feb 3.
PubMed 33535245Abuelniel G, Eltawil S. Clinical and Radiographic Evaluation of Stainless Steel versus Zirconia Crowns on Primary Molars: Randomized Controlled Trial. Egypt Dent J. 2018;64(2):977-89.
Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.
PubMed 32509626Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.
PubMed 25429038Attari N, Roberts JF. Restoration of primary teeth with crowns: a systematic review of the literature. Eur Arch Paediatr Dent. 2006 Jun;7(2):58-62; discussion 63. doi: 10.1007/BF03320816.
PubMed 17140529Abdulhadi B, Abdullah M, Alaki S, Alamoudi N, Attar M. Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth. J Pediatr Dent. 2017;5(1):21.
Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.
PubMed 25631720Schweiger J, Edelhoff D, Guth JF. 3D Printing in Digital Prosthetic Dentistry: An Overview of Recent Developments in Additive Manufacturing. J Clin Med. 2021 May 7;10(9):2010. doi: 10.3390/jcm10092010.
PubMed 34067212
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-Printed Crowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars; Randomized Clinical Trial and In-Vitro Study
- ClinicalTrials.gov ID
- NCT06068244
- Acronym / sponsor ID
- PED23-1D
- Conditions
- Dental Caries in Children
- Keywords
- "zirconia crowns", "pulpotomy", "3 dimension printed crowns"
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 5 Oct 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 aim of the present study is to compare between 3D-printed crowns and prefabricated zirconia crowns for restoring pulpally-treated primary molars regarding the following aspects:
- In vivo: Evaluate the clinical outcome of 3D printed crowns in comparison to prefabricated zirconia crowns in pulpally-treated primary molars as well as parent satisfaction.
- In vitro:
Comparative analysis of fracture resistance and marginal gap of 3D printed crowns and prefabricated zirconia crowns
Detailed description
in vitro part :
All selected primary molars should fulfill the following criteria:
- Freshly extracted molars with at least three sound walls.
- Retain at least one third of their roots Teeth preparation All soft tissue debris will be removed with a hand scaler and teeth will be disinfected, and then stored in distilled water at 4 degrees Celsius until the start of the study.
Pulpotomy procedures will be performed to the extracted molars and the molars will be filled. Then, they will be randomly allocated into two groups.
Group 1: Will receive 3D-printed crowns Group 2: Will receive prefabricated zirconia crowns The specimens will be embedded perpendicularly in Polyvinyl chloride (PVC) cubes with the occlusal surface parallel to the ground using acrylic resin extending 2mm below the cementoenamel junction.
Evaluations: teeth in both groups will be evaluated for the following:
- Marginal gap: Precementation measurements of the cervical vertical marginal discrepancies will be performed before cementation., Four optical images for each specimen will be captured using 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 (LLOYD 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.
in vivo part : Teeth will be polished using a polishing paste and brush, and dried before being examined.
A dental mirror will be used for clinical examination under light emitting diode (LED) illumination to confirm the fulfillment of the inclusion criteria of the patient's selection.
- The molars will be randomly allocated into two equal treatment groups 23/each):
- Group 1: 3D-printed crowns
- Group 2: prefabricated zirconia crowns Pulpotomy procedure for both groups: <!-- -->
- Local anesthesia will be administered.
- Teeth will undergo pulpotomy procedure' as follows:
- Caries removal will be done using a large size 4 round bur, mounted onto a high-speed hand piece with constant coolant.
- All access cavity walls will 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 control will be done using moist cotton pellet with gentle pressure.
- Formocresol will be applied using a cotton pellet for 3-5 mins, for fixation.
- The pulp chamber will be filled with re-inforced zinc oxide and eugenol that will be mixed according to manufacturer's instructions.
- Analgesics will be prescribed to the patient to be taken when needed.
Intervention Group 1:
- Crown reduction: The teeth will be prepared using taper diamond bur with round end for buccal, lingual, mesial, and distal wall for 0.8- 1 mm, producing a chamfer margin circumferentially, and then, reduction of the occlusal surface will be done using a round wheel to produce occlusal clearance of 1.5 mm.
- Impression for the preparation will be taken using putty and light poly vinyl siloxane material.
- The impression will be sent to the lab and the patient will be dismissed.
- The preparation will be optically scanned in the lab and the crown will be digitally designed using computer designing software.
- The crown will be printed using 3D printer.
- The 3D printed crown will be cemented in the 2nd visit.
Control: Group 2:
- Crown reduction:
- In order to compensate for the thickness of zirconia crown, reduction will be performed on the mesial, distal, buccal and lingual surfaces of the tooth for 0.7-1.75mm. Reduction will be performed using fine needle stone in the beginning to free the contact from the adjacent teeth then followed by reduction of the other surfaces using a diamond stone.
- Reduction of the occlusal surface will be performed using a flame stone or wheel stone to produce occlusal clearance of 1.5- 2 mm.
- All line angles will be checked to remove any sharp line angles.
- Selection of the matching size from zirconia crowns will be made taking into consideration that the preparation must be free from any undercuts to avoid crown fracture.
- After checking the selected size of the crowns, it will be removed, dried and cemented to the tooth using resin cement.
Method of evaluation:
After cementation , at baseline ,3rd ,6th and 12th months evaluation of the crowns will be performed clinically using the modified U.S. Public Health Service criteria for retention, marginal integrity and gingival health for both groups. Also, parental satisfaction will be evaluated at end of the study using 5-point likert scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed crowns | Experimental | Other: 3D printed crownsParticipants received 3D printed resin crowns |
| Zirconia crowns | Active comparator | Other: Zirconia crownsParticipants received ready made zirconia crowns |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children included in the study should stratify to the following criteria:
Key exclusion criteria (3 listed)
- a) Uncooperative children who needs sedation or general anesthesia. b) Children with physical, intellectual disability or medical conditions that may complicate treatment.
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 crowns3D printed crowns | Other | 3D printed crowns |
| Zirconia crownsNu smile zirconia crowns | Other | Zirconia crowns |
Primary outcome
Gingival health (gingival index)
Time frame: 1 year follow up for vivo part only
Gingival index and plaque index A gingival index, based on the Loe and Silness scoring criteria (1963). It will be measured by gently inserting the tip of a periodontal probe into the sulcus surrounding each tooth. Scoring as followed: 0 = Normal (Absence of inflammation) 1. = Mild gingivitis (slight change in color, slight edema. No bleeding on probing) 2. = Moderate gingivitis (redness, edema and glazing. Bleeding on probing) 3. = Severe gingivitis (marked redness and edema; ulceration; tendency to spontaneous bleeding) * Gingival index and plaque index.
plaque index
Time frame: 1year follow up
Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental Plaque index (PI) (Silness and Loe) PI 0: No observable plaque PI 1: A thin film of plaque is detected at the gingival margin by running a probe or explorer across the tooth surfaces PI 2: A moderate amount of plaque is detected along the gingival margin. Plaque is visible clinically. PI 3: Heavy plaque accumulation is detected at the gingival margin and in the interdental
Marginal integrity
Time frame: 1yeat follow up
by visual inspection and explorer Alfa: Explorer does not catch or has one way catch when drawn across the restoration/tooth interface. Bravo: Explorer falls into crevice when drawn across the restoration/tooth interface, Dentin is not exposed; clinically acceptable. Charlie: Dentin or base is exposed along the margin; clinically unacceptable.
crown retention
Time frame: one year follow up
Alpha: Bonded Bravo: Debonded Charlie: Lost
In vitro marginal gap
Time frame: Immediately after samples preparation
micrometers
in vitro fracture resistance
Time frame: Immediately after samples preparation
newton
1 secondary outcome
parent satisfaction
Time frame: immediately after cementation of crowns
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 5 Feb 2025.
- Background: PubMed 34285695Hamrah MH, Mokhtari S, Hosseini Z, Khosrozadeh M, Hosseini S, Ghafary ES, Hamrah MH, Narges Tavana. Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. Int J Dent. 2021 Jul 5;2021:7877728. doi: 10.1155/2021/7877728. eCollection 2021.
- Background: PubMed 33535245Al-Halabi MN, Bshara N, Nassar JA, Comisi JC, Rizk CK. Clinical Performance of Two Types of Primary Molar Indirect Crowns Fabricated by 3D Printer and CAD/CAM for Rehabilitation of Large Carious Primary Molars. Eur J Dent. 2021 Jul;15(3):463-468. doi: 10.1055/s-0040-1721905. Epub 2021 Feb 3.
- BackgroundAbuelniel G, Eltawil S. Clinical and Radiographic Evaluation of Stainless Steel versus Zirconia Crowns on Primary Molars: Randomized Controlled Trial. Egypt Dent J. 2018;64(2):977-89.
- Background: PubMed 32509626Mathew MG, Roopa KB, Soni AJ, Khan MM, Kauser A. Evaluation of Clinical Success, Parental and Child Satisfaction of Stainless Steel Crowns and Zirconia Crowns in Primary Molars. J Family Med Prim Care. 2020 Mar 26;9(3):1418-1423. doi: 10.4103/jfmpc.jfmpc_1006_19. eCollection 2020 Mar.
- Background: PubMed 25429038Ludwig KH, Fontana M, Vinson LA, Platt JA, Dean JA. The success of stainless steel crowns placed with the Hall technique: a retrospective study. J Am Dent Assoc. 2014 Dec;145(12):1248-53. doi: 10.14219/jada.2014.89.
- Background: PubMed 17140529Attari N, Roberts JF. Restoration of primary teeth with crowns: a systematic review of the literature. Eur Arch Paediatr Dent. 2006 Jun;7(2):58-62; discussion 63. doi: 10.1007/BF03320816.
- BackgroundAbdulhadi B, Abdullah M, Alaki S, Alamoudi N, Attar M. Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth. J Pediatr Dent. 2017;5(1):21.
- Background: PubMed 25631720Ashima G, Sarabjot KB, Gauba K, Mittal HC. Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. J Clin Pediatr Dent. 2014 Fall;39(1):18-22. doi: 10.17796/jcpd.39.1.t6725r5566u4330g.
- Background: PubMed 34067212Schweiger J, Edelhoff D, Guth JF. 3D Printing in Digital Prosthetic Dentistry: An Overview of Recent Developments in Additive Manufacturing. J Clin Med. 2021 May 7;10(9):2010. doi: 10.3390/jcm10092010.
- 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.
Geham Gaber allam study director
Assistant professor
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 crowns and Zirconia crowns in people with Dental Caries in Children, 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 5 Feb 2025. 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?
Gingival health (gingival index) (time frame: 1 year follow up for vivo part only). The study lists 6 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 NCT06068244, which also lists 9 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 5 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.