3D-printed Crowns Versus Zirconia Crowns for Primary Molars
NCT ID: NCT06068244
Last Updated: 2025-02-05
Study Results
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Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2023-07-01
2024-11-30
Brief Summary
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1. 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.
2. In vitro:
Comparative analysis of fracture resistance and marginal gap of 3D printed crowns and prefabricated zirconia crowns
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Detailed Description
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All selected primary molars should fulfill the following criteria:
1. Freshly extracted molars with at least three sound walls.
2. 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:
1. 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.
2. 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):
1. Group 1: 3D-printed crowns
2. Group 2: prefabricated zirconia crowns
Pulpotomy procedure for both groups:
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1. Local anesthesia will be administered.
2. 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:
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.
2. Impression for the preparation will be taken using putty and light poly vinyl siloxane material.
3. The impression will be sent to the lab and the patient will be dismissed.
4. The preparation will be optically scanned in the lab and the crown will be digitally designed using computer designing software.
5. The crown will be printed using 3D printer.
6. The 3D printed crown will be cemented in the 2nd visit.
Control: Group 2:
1. 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.
2. 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.
3. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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3D printed crowns
Participants received 3D printed resin crowns
3D printed crowns
3D printed crowns
Zirconia crowns
Participants received ready made zirconia crowns
Zirconia crowns
Nu smile zirconia crowns
Interventions
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3D printed crowns
3D printed crowns
Zirconia crowns
Nu smile zirconia crowns
Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
c) Teeth with poor prognosis due to the presence of an abscess or a sinus, mobility or advanced bone resorption.
d) Presence of internal or external root resorption.
4 Years
7 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Esaad El Nagar
Assistant lecturer at pediatric dentistry and dental public health department
Principal Investigators
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Geham Gaber allam
Role: STUDY_DIRECTOR
Assistant professor
Locations
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Ain shams university
Cairo, , Egypt
Countries
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References
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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.
Al-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.
Abuelniel 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.
Ludwig 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.
Attari 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.
Abdulhadi 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.
Schweiger 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.
Other Identifiers
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PED23-1D
Identifier Type: -
Identifier Source: org_study_id
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