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

Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468085
• Other study ID #: FDASU-Rec ID032421
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: Ain Shams University
• Contact: Sally Emad, BDS,MSc
• Phone: 01227788137
• Email: sallyghobrial[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: July 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Radiographic success	No Internal or external root resorption. No Periapical radiolucency.	3, 6, 9 and 12 months follow up
Secondary	Evaluation of tooth discoloration.	Evaluation of tooth discoloration using the VITA Easyshade V digital spectrophotometer.	3, 6, 9 and 12 months follow up