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NCT Number: NCT07344038

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

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.

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Key information

Conditions

Caries Active

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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

Primary outcomes

  1. clinical success of pulpotomy at 1 week

    Time frame: clinical success at 1 week

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

  2. clinical success of pulpotomy at 6 months

    Time frame: clinical success at 6 months

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

  3. clinical success of pulpotomy at 12 months

    Time frame: clinical success at 12 months

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

  4. radiographic success of pulpotomy at 1 week

    Time frame: radiographic success at 1 week

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

  5. radiographic success of pulpotomy at 6 months

    Time frame: radiographic success at 6 months

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

  6. radiographic success of pulpotomy at 12 months

    Time frame: radiographic success at 12 months

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

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

    Time frame: 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

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

    Time frame: 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

Secondary outcomes

  1. 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

    1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied

  2. 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

    1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied

  3. 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

    1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied

  4. 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

    1 Very dissatisfied 2 Dissatisfied 3 Neutrally satisfied 4 Satisfied 5 Very satisfied

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

    Time frame: immediately after crown cementation

    Child Satisfaction (Smiley Face Likert Scale) awful not very good good really good fantastic

Study contacts

Contact information is provided by the study sponsor or research team.

yousr nader pediatric dentist specialist, doctorate

CONTACT

[email protected]

[email protected]

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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