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

NCT07344038 | Recruiting FDA Device

• 1 other identifier: 1155-10/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MTA, bioceramic putty, 3D printed resin crowns, stainless steel crowns

Outcome Measures

Primary Outcomes (8)

• clinical success of pulpotomy at 1 week

  Clinical success: Absence of pain, sensitivity to percussion, swelling, or fistula.

  clinical success at 1 week

• clinical success of pulpotomy at 6 months

  Absence of pain, sensitivity to percussion, swelling, or fistula.

  clinical success at 6 months

• clinical success of pulpotomy at 12 months

  Absence of pain, sensitivity to percussion, swelling, or fistula.

  clinical success at 12 months

• radiographic success of pulpotomy at 1 week

  No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.

  radiographic success at 1 week

• radiographic success of pulpotomy at 6 months

  No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.

  radiographic success at 6 months

• radiographic success of pulpotomy at 12 months

  No periodontal ligament space widening, resorption, or periapical/furcal radiolucency.

  radiographic success at 12 months

• Crown evaluation at 6 months using Modified United States Public Health Service

  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

  at 6 months

• crown evaluation at 12 months using Modified United States Public Health Service

  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

  at 12 months

Secondary Outcomes (5)

• Parental satisfaction Assessed immediately after treatment using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction

  immediately after treatment

• Parental satisfaction Assessed after 1 week using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction

  parental satisfaction after 1 week

• parental satisfaction assessed after 6 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction

  parental satisfaction after 6 months

• parental satisfaction assessed after 12 months using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction

  parental satisfaction after 12 months

• Child satisfaction Measured immediately post-cementation using a Smiley Face Likert scale in child-friendly language.

  immediately after crown cementation

Study Arms (4)

Endo-sequence bioceramic putty pulpotomy

EXPERIMENTAL

Procedure: Endo-sequence bioceramic putty pulpotomy

Bio MTA+

ACTIVE COMPARATOR

Procedure: Bio MTA+ pulpotomy

3D-printed ceramic-filled hybrid resin crowns

EXPERIMENTAL

Device: 3D-Printed Resin Crowns

Stainless steel crowns

ACTIVE COMPARATOR

Device: Stainless Steel Crowns (SSCs)

Interventions

Bio MTA+ pulpotomy PROCEDURE

* 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.

Bio MTA+

Stainless Steel Crowns (SSCs) DEVICE

* 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.

Stainless steel crowns

3D-Printed Resin Crowns DEVICE

* 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

3D-printed ceramic-filled hybrid resin crowns

Endo-sequence bioceramic putty pulpotomy PROCEDURE

* 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.

Endo-sequence bioceramic putty pulpotomy

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Deep carious second primary molars with:
• Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.
• Signs of reversible pulpitis. 10
• Require full coverage restorations
• Cooperative children (Frankl 3 or 4 behavior rating scale)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

RECRUITING

Related Publications (1)

• American Academy of Pediatric Dentistry. Pulp therapy for primary and immature permanent teeth Chicago (IL): American Academy of Pediatric Dentistry; 2023. 2. Abdelwahab DH KN, Badran AS, Darwish D, Abd El Geleel OM. Oneyear radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial. J Dent 2024;143:104864. 3. Wang Z. Bioceramic materials in endodontics. Endod Topics 2015;32:3- 30. 4. Mahgoub N, Alqadasi B, Aldhorae K, Assiry A, Altawili ZM, Tao H. Comparison between iRoot BP Plus (EndoSequence Root Repair Material) and Mineral Trioxide Aggregate as Pulp-capping Agents: A Systematic Review. J Int Soc Prev Community Dent 2019;9:542-52. 5. Moazzami F, Sahebi S, Shirzadi S, Azadeh N. Comparative in vitro Assessment of Tooth Color Change under the Influence of Nano Fast Cement and MTA. J Dent (Shiraz) 2021;22:48-52. 6. Ayoub KM, Nagy MM, Aly RM, El Deen GN, El-Batouty K. Effect of Bio MTA plus & ProRoot MTA pulp capping materials on the regenerative properties of human dental pulp stem cells. Sci Rep 2025;15:4749. 7. Voicu G, Didilescu AC, Stoian AB, Dumitriu C, Greabu M, Andrei M. Mineralogical and Microstructural Characteristics of Two Dental Pulp Capping Materials. Materials (Basel) 2019;12:1772. 25 8. Kiranmayi T, Vemagiri CT, Rayala C, Chandrappa V, Bathula H, Challagulla A. In vivo comparison of bioceramic putty and mineral trioxide aggregate as pulpotomy medicament in primary molars. A 12- month follow-up randomized clinical trial. Dent Res J (Isfahan) 2022;19:84. 9. Alqahtani AS, Alsuhaibani NN, Sulimany AM, Bawazir OA. NeoPUTTY(®) Versus NeoMTA 2(®) as a Pulpotomy Medicament for Primary Molars: A Randomized Clinical Trial. Pediatr Dent 2023;45:240-4. 10. Arvelaiz C, Fernandes A, Graterol V, Gomez K, Gomez-Sosa JF, Caviedes-Bucheli J, et al. In Vitro Comparison of MTA and BC RRMFast Set Putty as Retrograde Filling Materials. Eur Endod J 2022;7:203- 9. 11. Motwani N, Ikhar A, Nikhade P, Chandak M, Rathi

  BACKGROUND

Central Study Contacts

yousr nader pediatric dentist specialist, doctorate

CONTACT

yousr.nader@gmail.com; yousr.nader@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric dentistry specialist

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 15, 2026
• Study Start: January 20, 2026
• Primary Completion: February 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

EG (1)