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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
in vitro part :
All selected primary molars should fulfill the following criteria:
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:
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:
Control: Group 2:
Crown reduction:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D printed crowns | Experimental | Participants received 3D printed resin crowns |
|
| Zirconia crowns | Active Comparator | Participants received ready made zirconia crowns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printed crowns | Other | 3D printed crowns |
| |
| Zirconia crowns |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 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 | 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. | 1yeat follow up |
| crown retention | Alpha: Bonded Bravo: Debonded Charlie: Lost | one year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| parent satisfaction | 5-point likert scale.1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied. | immediately after cementation of crowns |
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Inclusion Criteria:
Children included in the study should stratify to the following criteria:
Exclusion Criteria:
a) Uncooperative children who needs sedation or general anesthesia. b) Children with physical, intellectual disability or medical conditions that may complicate treatment.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Geham Gaber allam | Assistant professor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34285695 | Background | 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. | |
| 33535245 | Background |
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| Other |
Nu smile zirconia crowns |
|
| In vitro marginal gap | micrometers | Immediately after samples preparation |
| in vitro fracture resistance | newton | Immediately after samples preparation |
| 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. |
| Background | 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. |
| 32509626 | Background | 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. |
| 25429038 | Background | 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. |
| 17140529 | Background | 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. |
| Background | 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. |
| 25631720 | Background | 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. |
| 34067212 | Background | 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. |