Clinical trial NCT06468085: Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pulpitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 48
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two study groups and one control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical success
timeFrame: 3, 6, 9 and 12 months follow up
measure: Radiographic success
timeFrame: 3, 6, 9 and 12 months follow up
Secondary outcomes:
measure: Evaluation of tooth discoloration.
timeFrame: 3, 6, 9 and 12 months follow up
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Nagwa Khattab, BDS,MSc, MD
role: STUDY_DIRECTOR
References: