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

Clinical and Radiographic Evaluation of Premixed Bioceramic Putty and Biodentine™ Pulpotomy in Mature Permanent Anterior Teeth With Signs of Pulpitis: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulpitis
• Intervention / Treatment: Procedure: premixed Bioceramic NeoPUTTY®; Procedure: Biodentine™; Procedure: Root canal treatment

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally Emad, BDS,MSc; Phone Number: 01227788137; Email: sallyghobrial@dent.asu.edu.eg
• Study Contact Backup: Name: Dina Darwish, BDS,MSc, MD; Email: dinadarwish@dent.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Experimental: 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.	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.
Active Comparator: Group C: the root canal treatment group; Root canal treatment will be performed to the control group followed by composite restoration.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success	Absence of pain related to the treated teeth, including patient reported pain or sensitivity to percussion/palpation. No evidence of swelling of supporting soft tissue or presence of sinus tract. Absence of excessive mobility affecting treated teeth.	3, 6, 9 and 12 months follow up
Radiographic success	No Internal or external root resorption. No Periapical radiolucency.	3, 6, 9 and 12 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of tooth discoloration.	Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer.	3, 6, 9 and 12 months follow up

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nagwa Khattab, BDS,MSc, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 15, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: FDASU-Rec ID032421

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No