Ain shams university
Cairo, Egypt
NCT Number: NCT06068244
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. 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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Notify Me4 year–7 year
All sexes
Interventional
Not applicable
Cairo, Egypt
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:
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.
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.
Pulpotomy procedure for both groups:
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Intervention Group 1:
Control: Group 2:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
3D printed crowns
Nu smile zirconia crowns
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)
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
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.
Time frame: one year follow up
Alpha: Bonded Bravo: Debonded Charlie: Lost
Time frame: Immediately after samples preparation
micrometers
Time frame: Immediately after samples preparation
newton
Time frame: immediately after cementation of crowns
5-point likert scale.1-very dissatisfied; 2-dissatisfied; 3-neutrally satisfied; 4-satisfied; 5-very satisfied.
Ain Shams University
Other
3D-Printed Crowns Versus Prefabricated Zirconia Crowns for the Restoration of Pulpally-treated Primary Molars; Randomized Clinical Trial and In-Vitro Study
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