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3D-printed Crowns Versus Zirconia Crowns for Primary Molars

Primary Purpose

Dental Caries in Children

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D printed crowns
Zirconia crowns
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring "zirconia crowns", "pulpotomy", "3 dimension printed crowns"

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

  • Ain shams universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3D printed crowns

Zirconia crowns

Arm Description

Participants received 3D printed resin crowns

Participants received ready made zirconia crowns

Outcomes

Primary Outcome Measures

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.
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
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.
crown retention
Alpha: Bonded Bravo: Debonded Charlie: Lost
In vitro marginal gap
micrometers
in vitro fracture resistance
newton

Secondary Outcome Measures

parent satisfaction
5-point likert scale.1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied.

Full Information

First Posted
September 8, 2023
Last Updated
September 28, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT06068244
Brief Title
3D-printed Crowns Versus Zirconia Crowns for Primary Molars
Official Title
3D-Printed Crowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars; Randomized Clinical Trial and In-Vitro Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
"zirconia crowns", "pulpotomy", "3 dimension printed crowns"

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D printed crowns
Arm Type
Experimental
Arm Description
Participants received 3D printed resin crowns
Arm Title
Zirconia crowns
Arm Type
Active Comparator
Arm Description
Participants received ready made zirconia crowns
Intervention Type
Other
Intervention Name(s)
3D printed crowns
Intervention Description
3D printed crowns
Intervention Type
Other
Intervention Name(s)
Zirconia crowns
Intervention Description
Nu smile zirconia crowns
Primary Outcome Measure Information:
Title
Gingival health (gingival index)
Description
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.
Time Frame
1 year follow up for vivo part only
Title
plaque index
Description
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
Time Frame
1year follow up
Title
Marginal integrity
Description
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.
Time Frame
1yeat follow up
Title
crown retention
Description
Alpha: Bonded Bravo: Debonded Charlie: Lost
Time Frame
one year follow up
Title
In vitro marginal gap
Description
micrometers
Time Frame
Immediately after samples preparation
Title
in vitro fracture resistance
Description
newton
Time Frame
Immediately after samples preparation
Secondary Outcome Measure Information:
Title
parent satisfaction
Description
5-point likert scale.1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied.
Time Frame
immediately after cementation of crowns

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
esaad ibrahim, Assistant Lecturer
Phone
01092585461
Email
Esaadelnagar14@hotmail.com
Facility Information:
Facility Name
Ain shams university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esaad Ibrahim Abdelaziz
Phone
Assistant lecturer
Email
esaadelnagar14@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34285695
Citation
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Results Reference
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PubMed Identifier
33535245
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
32509626
Citation
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.
Results Reference
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PubMed Identifier
25429038
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
25631720
Citation
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.
Results Reference
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Citation
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.
Results Reference
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3D-printed Crowns Versus Zirconia Crowns for Primary Molars

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