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.
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.
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.
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
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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
7 Years
Healthy volunteers
No
Inclusion Criteria:
* Children aged from 5 to 7 years. 2. Medically healthy children (ASA I) (Appendix I) 3. Positive or definitely positive behavior (Frankl's rating scale scores III or IV) (Appendix II) 4. Parents/legal guardians who provide written informed consent Tooth inclusion criteria(8, 14, 31)
1. Deep carious second primary molars with:
1. Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.
2. Signs of reversible pulpitis. 10
2. Require full coverage restorations
3. Cooperative children (Frankl 3 or 4 behavior rating scale)
Exclusion Criteria:
* History of spontaneous pain. 2. Tooth mobility. 3. Excessive bleeding from radicular stumps after coronal pulp amputation. 4. Radiographic evidence of pathological root resorption, inter-radicular bone loss, periapical pathology, or canal calcifications. 5. Previous dental treatment of the involved molar. 6. Children with special healthcare needs.
Primary outcome measure(s)
clinical success of pulpotomy at 1 week — clinical success at 1 week Clinical success: Absence of pain, sensitivity to percussion, swelling, or fistula.
clinical success of pulpotomy at 6 months — clinical success at 6 months Absence of pain, sensitivity to percussion, swelling, or fistula.
clinical success of pulpotomy at 12 months — clinical success at 12 months Absence of pain, sensitivity to percussion, swelling, or fistula.
radiographic success of pulpotomy at 1 week — radiographic success at 1 week No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
radiographic success of pulpotomy at 6 months — radiographic success at 6 months No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
radiographic success of pulpotomy at 12 months — radiographic success at 12 months No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.
Crown evaluation at 6 months using Modified United States Public Health Service — at 6 months Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion.
Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear.
Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C
crown evaluation at 12 months using Modified United States Public Health Service — at 12 months Resistance to dislodgment Alpha: Snap-fit retention Bravo: Partial retention Charlie: No retention Crown - high in occlusion Alpha: Ideal, with the crown being in harmony with occlusion.
Bravo: Clinically acceptable, with the crown occluding slightly high or low in occlusion. Charlie: Clinically unacceptable, with the crown needing to be replaced. Retention of crown after cementation Alpha: Intact Bravo: Chipped/loss of material Charlie: Complete loss of crown Occlusal wear of crown Alpha: Occlusal surface intact. Bravo: Wear of occlusal surface without tooth surface exposure. Charlie: Wear of occlusal surface with tooth surface exposure. Wear of opposing crown or tooth Alpha: Clinically ideal, with no evidence of wear.
Bravo: Clinically acceptable, with mild wear of the opposing tooth. Charlie: Clinically unacceptable, with severe wear of the opposing tooth. Marginal integrity and discoloration Alpha: Clinically ideal, with no evidence of gap along the gingival crown margin. Bravo: C
Trial sites (1)
Facility
City
Region
Status
Faculty of Dentistry, Alexandria University, Egypt
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.