NCT07344038

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

Effectiveness of Bioceramic Calcium Silicate-based Pulpotomy Medicament on Primary Molars Restored With 3d Printed Resin Crowns (a Randomized Controlled Clinical Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 5 Years – 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

removal of caries from second primary molars reaching the pulp, pulpotomy will be done by controlling the bleeding after that pulp chamber will be covered with either MTA or endosequence bioceramic putty. resin modified glass ionomer will be placed, crown preparation will be done to receive full coverage either stainless steel crowns or 3D printed resin crowns

Conditions

• Caries Active

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-02-15
• Completion: 2027-04-15
• First posted: 2026-01-15
• Last updated: 2026-01-15

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study