Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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biodentine

pulptomy with biodentine

Group Type ACTIVE_COMPARATOR

vital pulp therapy

Intervention Type PROCEDURE

pulpotomy

Theracal PT

pulpotomy with Theracal PT

Group Type ACTIVE_COMPARATOR

vital pulp therapy

Intervention Type PROCEDURE

pulpotomy

Neo Putty

pulpotomy with Neo putty

Group Type ACTIVE_COMPARATOR

vital pulp therapy

Intervention Type PROCEDURE

pulpotomy

Interventions

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vital pulp therapy

pulpotomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes