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Clinical Trials/NCT04933955
NCT04933955
Unknown
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Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )

Ain Shams University1 site in 1 country60 target enrollmentJune 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Root Canal Infection
Sponsor
Ain Shams University
Enrollment
60
Locations
1
Primary Endpoint
post operative pain
Last Updated
4 years ago

Overview

Brief Summary

The aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.

Detailed Description

Setting and location : Out-patients clinic of Endodontic Department, Faculty of Dentistry, Ain Shams University Patient allocation: Using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups . The sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned. Patient Classification: Patients will be randomly divided into three groups according to material used in pulpotomy Group (1) Biodentine (n=20) Group (2) theracal PT (n=20) Group (3) Neoputty (n=20) Procedural steps: * Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (VAS) * Tooth will be anaesthetized using Local anesthesia containing Articaine with epinephrine 1:100,000. * Rubber dam isolation of tooth * Tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite * Access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing. * Using a sterile excavator, the coronal pulp tissue will be excavated14 * Cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes * Once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions * Final restoration will be placed Methods of evaluation 1. Post operative pain 2. Pulpotomy success rate

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shehab El Din Mohamed Saber

professor

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • Patients age between 20 and 40 years old.
  • Teeth diagnosed with symptomatic irreversible pulpitis.
  • Normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the PDL space.
  • The teeth are restorable.
  • Teeth probing depth and mobility should be within normal limits.

Exclusion Criteria

  • Teeth with immature roots
  • Non restorable teeth
  • Bleeding could not be controlled after pulpotomy in 10 minutes.
  • Medically compromised patients with systemic complication that would alter the treatment.

Outcomes

Primary Outcomes

post operative pain

Time Frame: 72 hours following the end of the procedure.

Each patient will be asked to fill the visual analogue scale to rate the pain level

Secondary Outcomes

  • Pulpotomy success(18 months after the intervention)

Study Sites (1)

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