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

ConditionCaries Active
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-7
SponsorAlexandria University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.

Signs of reversible pulpitis. 10

Require full coverage restorations

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endo-sequence bioceramic putty pulpotomy

    Procedure/Surgery

    * 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/Surgery

    * 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

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Endo-sequence bioceramic putty pulpotomyExperimental treatment 1 intervention
Group B: Bio MTA+Active comparator 1 intervention
Group C: 3D-printed ceramic-filled hybrid resin crownsExperimental treatment 1 intervention
Group D: Stainless steel crownsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

clinical success of pulpotomy at 1 week

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

Time frame
clinical success at 1 week
2

clinical success of pulpotomy at 6 months

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

Time frame
clinical success at 6 months
3

clinical success of pulpotomy at 12 months

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

Time frame
clinical success at 12 months
4

radiographic success of pulpotomy at 1 week

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

Time frame
radiographic success at 1 week

Secondary outcomes

1

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

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

Time frame
immediately after treatment
2

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

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

Time frame
parental satisfaction after 1 week
3

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

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

Time frame
parental satisfaction after 6 months
4

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

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

Time frame
parental satisfaction after 12 months

Other outcomes

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