Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Ain Shams University

Status: Unknown

Conditions: Root Canal Infection

Treatments: Procedure: vital pulp therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04933955

7/6/21

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

biodentine

Active Comparator group

Description:

pulptomy with biodentine

Treatment:

Procedure: vital pulp therapy

Theracal PT

Active Comparator group

Description:

pulpotomy with Theracal PT

Treatment:

Procedure: vital pulp therapy

Neo Putty

Active Comparator group

Description:

pulpotomy with Neo putty

Treatment:

Procedure: vital pulp therapy