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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two study groups and one control group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Double Blind study, where participants will be blinded to the study groups they are randomized to, statisticians will be blinded while performing statistical analysis. On the other hand, the operator/primary investigator cannot be blinded as she is already familiar with the tooth and materials used and their different application. Also, the outcome assessor is not blinded due to the difference between the used materials.

Study Groups

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Group A: The premixed Bioceramic NeoPUTTY® 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 NeoPUTTY® then final composite restoration will be applied.

Group Type EXPERIMENTAL

premixed Bioceramic NeoPUTTY®

Intervention Type PROCEDURE

Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Group B: The Biodentine™ 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 Biodentine™ then final composite restoration will be applied.

Group Type EXPERIMENTAL

Biodentine™

Intervention Type PROCEDURE

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. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Group C: the root canal treatment group

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

Group Type ACTIVE_COMPARATOR

Root canal treatment

Intervention Type PROCEDURE

Root canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Interventions

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premixed Bioceramic NeoPUTTY®

Pulpotomy procedure will be performed after hemostasis followed by covering pulp stump with Premixed Bioceramic then final composite restoration will be applied. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Intervention Type PROCEDURE

Biodentine™

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. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Intervention Type PROCEDURE

Root canal treatment

Root canal treatment will be performed to the control group followed by composite restoration. clinical evaluation will be done at baseline, 3, 6, 9 and 12 months.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes