Evaluation of Post Operative Pain and Success Rate After Pulpotomy

Study 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 Post operative pain Pulpotomy success rate

Official Title
-----------------
Comparative Evaluation of Post Operative Pain and Success Rate After Pulpotomy Using Different Tricalcium Silicate Based Materials (A Randomized Clinical Trial )

Conditions
-----------------
Root Canal Infection

Intervention / Treatment
-----------------
* Procedure: vital pulp therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: biodentine<br>pulptomy with biodentine | Procedure: vital pulp therapy<br>* pulpotomy<br>|
| Active Comparator: Theracal PT<br>pulpotomy with Theracal PT | Procedure: vital pulp therapy<br>* pulpotomy<br>|
| Active Comparator: Neo Putty<br>pulpotomy with Neo putty | Procedure: vital pulp therapy<br>* pulpotomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | pre-operative | 
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 6 hours following the end of the procedure. | 
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 12 hours following the end of the procedure. | 
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 24 hours following the end of the procedure. | 
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 48 hours following the end of the procedure. | 
| post operative pain | Each patient will be asked to fill the visual analogue scale to rate the pain level | 72 hours following the end of the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulpotomy success | clinical and radiographic absence of inflammation | 3 months after the intervention | 
| Pulpotomy success | clinical and radiographic absence of inflammation | 6 months after the intervention | 
| Pulpotomy success | clinical and radiographic absence of inflammation | 9 months after the intervention | 
| Pulpotomy success | clinical and radiographic absence of inflammation | 12 months after the intervention | 
| Pulpotomy success | clinical and radiographic absence of inflammation | 18 months after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulpotomy, Tricalcium silicate, Biodentine, vital pulp therapy