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

Official title

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

Overview

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

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.

Primary outcome measures

• clinical success of pulpotomy at 1 week [Time frame: clinical success at 1 week]
• clinical success of pulpotomy at 6 months [Time frame: clinical success at 6 months]
• clinical success of pulpotomy at 12 months [Time frame: clinical success at 12 months]
• radiographic success of pulpotomy at 1 week [Time frame: radiographic success at 1 week]
• radiographic success of pulpotomy at 6 months [Time frame: radiographic success at 6 months]
• radiographic success of pulpotomy at 12 months [Time frame: radiographic success at 12 months]
• Crown evaluation at 6 months using Modified United States Public Health Service [Time frame: at 6 months]
• crown evaluation at 12 months using Modified United States Public Health Service [Time frame: at 12 months]

Secondary outcome measures (5)

• Parental satisfaction Assessed immediately after treatment using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction [Time frame: immediately after treatment]
• Parental satisfaction Assessed after 1 week using a 5-point Likert scale concerning appearance, color, size, durability, and overall satisfaction [Time frame: 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 [Time frame: 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 [Time frame: parental satisfaction after 12 months]
• Child satisfaction Measured immediately post-cementation using a Smiley Face Likert scale in child-friendly language. [Time frame: immediately after crown cementation]

Eligibility criteria

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)

• 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)

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Dentistry, Alexandria University, Egypt — Alexandria

Publications

• 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

Identifiers

NCT: NCT07344038 · 1155-10/2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗