Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis

Ain Shams University

Status: Not yet enrolling

Conditions: Pulpitis

Treatments: Procedure: Root canal treatment; Procedure: premixed Bioceramic NeoPUTTY®; Procedure: Biodentine™

Study type: Interventional

Funder types: Other

Identifiers

NCT06468085

FDASU-Rec ID032421

Details and patient eligibility

About

the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.

Full description

In this randomized controlled trial, A total number of 75 mature vital permanent anterior teeth with recent trauma or deep caries in children aged between 9 and 14 years will be included. Patients will be randomly allocated into three study groups: group A (premixed bioceramic NeoPutty®) test group, group B (Biodentine™) test group and group C (root canal treatment) control group. Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic or Biodentine™ according to the corresponding group then final composite restoration will be applied. Root canal treatment will be performed to the control group followed by composite restoration. Blinded clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Enrollment: 48 estimated patients

Sex: All

Ages: 9 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children and adolescents of both sexes aged between 9 and 14 years old.
• Vital mature permanent anterior teeth with deep caries lesions that approach the pulp with signs of pulpitis and respond positive to cold pulp testing.
• Vital mature permanent anterior teeth with pulpal exposure that occurred during caries excavation.
• Patients presented immediately after suffering recent trauma (at the same day) to mature anterior teeth that had resulted in a crown fracture with pulp exposure.

Exclusion criteria

• Teeth with signs of infection such as swelling, sinus tract or pathological mobility or excessive mobility.
• Teeth with excessive bleeding from amputated radicular stumps
• Teeth showing radiographic evidence of pathologic root resorption, periapical pathology and calcifications in the canals.
• Lack of patient/parent compliance and cooperation.
• Children who are physically or mentally disabled or having any medical condition that will complicate the treatment.
• Patients allergic to any medicaments used.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Group A: The premixed Bioceramic NeoPUTTY® group

Experimental group

Description:

Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic NeoPUTTY® then final composite restoration will be applied.

Treatment:

Procedure: premixed Bioceramic NeoPUTTY®

Group B: The Biodentine™ group

Experimental group

Description:

Cases will be evaluated clinically and radiographically to obtain baseline data. Local anesthesia will be administered and then rubber dam isolation will be performed. Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Biodentine™ then final composite restoration will be applied.

Treatment:

Procedure: Biodentine™

Group C: the root canal treatment group

Active Comparator group

Description:

Root canal treatment will be performed to the control group followed by composite restoration.

Treatment:

Procedure: Root canal treatment