Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Not Applicable

• Conditions: Root Canal Infection
• Interventions: Procedure: vital pulp therapy

• Registration Number: NCT04933955
• Lead Sponsor: Ain Shams University

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

Study Timeline

• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-14
• Last Update Submitted: 2021-06-14
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-22
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theracal PT	vital pulp therapy	pulpotomy with Theracal PT
biodentine	vital pulp therapy	pulptomy with biodentine
Neo Putty	vital pulp therapy	pulpotomy with Neo putty

Primary Outcome Measures

Name	Time	Method
post operative pain	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 Outcome Measures

Name	Time	Method
Pulpotomy success	18 months after the intervention	clinical and radiographic absence of inflammation

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt