Effect of Cryotherapy on Postoperative Pain

Study Overview
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Brief Summary
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the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

Detailed Description
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the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

Official Title
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Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Procedure: cryotherapy
* Procedure: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-40 years old. Systemically healthy patient (ASA I or II). mandibular first molar teeth with: Preoperative sharp pain and Symptomatic apical periodontitis .absence or slight widening in the periodontal ligament (PDL). .Vital response of pulp tissue to cold pulp tester (ethyl chloride spray). Ability for isolation with rubberdam. Restorable teeth Ability to fill the root canals in single visit treatment. Exclusion Criteria: Teeth without good apical constriction, such as wide or open apex Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females. Patients having significant systemic disorder (ASA III or IV). Teeth that have : Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A random sequence will be generated by computer software, (http://www.random.org/). The table will be kept with the assistant supervisor.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cryotherapy<br>2.5c cold saline as a final flush after chemicomechanical debridement | Procedure: cryotherapy<br>* 2.5c cold saline is used as a final flush after chemomechanical preparation<br>|
| Other: normal saline<br>room temperature saline is used as a final flush after chemicomechanical preparation | Procedure: normal saline<br>* a room temperature saline is used as a final flush after mechanical preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain assessed by NRS | Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents no pain 1- 3: readings represent mild pain 4- 6: readings represent moderate pain 7- 10: readings represent severe pain | up to 48 hrs postoperative pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of analgesics assessed by counting | number of analgesics tablets up to 48 hrs postoperatively | up to 48 hrs postoperatively |