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Bioceramic Putty Versus MTA in Pulpotomized Primary Teeth to be Covered With 3D Printed Resin Crowns Versus Stainless Steel Crown

NCT07344038 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-15

No results posted yet for this study

Summary

children aged 5 to 7 years with deep carious second primary molars that require vital pulp therapy will be treated using either MTA or bioceramic putty, then will be fully covered using either stainless steel crowns or 3D printed resin crowns.

Conditions

  • Caries Active

Interventions

PROCEDURE

Endo-sequence bioceramic putty pulpotomy

* Profound local anesthesia and rubber dam isolation will be applied. * Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing. * Coronal pulp will be removed with a sharp excavator. * Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes. * Bioceramic putty applied directly from the manufacturer's syringe, then adapted gently with a moist cotton pellet.

PROCEDURE

Bio MTA+ pulpotomy

* Profound local anesthesia and rubber dam isolation will be applied. * Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing. * Coronal pulp will be removed with a sharp excavator. * Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes. * The MTA powder will be mixed with the liquid to a putty consistency and applied with an amalgam carrier.

DEVICE

Stainless Steel Crowns (SSCs)

* Occlusal reduction of 1.0-1.5 mm using a flame-shaped diamond bur. * Interproximal slicing to enable passive crown placement. * Crown size selection based on best fit. * Cementation using RMGIC. * Excess cement will be removed.

DEVICE

3D-Printed Resin Crowns

* Tooth preparation: 1 mm axial reduction with a chamfer finish line using tapered diamond stone with round end (Mani TR-12) for buccal, lingual, mesial, and distal walls. * One and half - 2 mm occlusal reduction. * Digital impressions using IOS scanning, including occlusion and antagonist. * 3D printed resin crowns will be designed using the Exocad software (Exocad Rigeka 3.1) to have a uniform thickness on all surfaces (average 1 mm), including occlusal, buccal, lingual, and proximal surfaces. After reviewing each design, it will be exported as a high-resolution STL file (standard tessellation language) to be outsourced and 3D printed. * BEGO DLP printer will be utilized to print the crowns using VarseoSmile Trinique resin via digital light processing (DLP) technique. * After printing, the platform will be removed from the 3D printer and placed on a paper towel with the printed crowns facing upward. * The printed crowns will be separated from the platform and rinsed tw

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-02-15
Completion
2027-04-15
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344038 on ClinicalTrials.gov