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

NCT06468085 | Not Yet Recruiting

• 1 other identifier: FDASU-Rec ID032421
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Evaluation of tooth discoloration.

  3, 6, 9 and 12 months follow up

Study Arms (3)

Group A: The premixed Bioceramic NeoPUTTY® group

EXPERIMENTAL

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®

Group B: The Biodentine™ group

EXPERIMENTAL

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™

Group C: the root canal treatment group

ACTIVE COMPARATOR

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

Procedure: Root canal treatment

Interventions

premixed Bioceramic NeoPUTTY® 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 A: The premixed Bioceramic NeoPUTTY® group

Biodentine™ 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 B: The Biodentine™ group

Root canal treatment 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.

Group C: the root canal treatment group

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pulpitis

Interventions

tricalcium silicate

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nagwa Khattab, BDS,MSc, MD

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Sally Emad, BDS,MSc

CONTACT

01227788137; sallyghobrial@dent.asu.edu.eg

Dina Darwish, BDS,MSc, MD

CONTACT

dinadarwish@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: two study groups and one control group

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06