Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain

Study Overview
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Brief Summary
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The aim of this study is to clinically compare the efficacy of intraoral cryotherapy versus intracanal cryotherapy after single visit root canal therapy in lower molars with irreversible pulpitis and symptomatic apical periodontitis

Official Title
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Comparative Evaluation of the Efficacy of Intraoral Cryotherapy Versus Intracanal Cryotherapy on Postoperative Pain in Lower Molar Teeth With Irreversible Pulpitis and Symptomatic Apical Periodontitis Randomized Clinical Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Intraoral Cryotherapy
* Procedure: Intracanal Cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) . Positive response to percussion test Exclusion Criteria: Medically compromised patients. Pregnant women. Patients reporting bruxism or clenching. Patients allergic to ciprofloxacin or metronidazole. Teeth associated with acute periapical abscess and/or swelling. Greater than grade I mobility or pocket depth greater than 5mm. Size of periapical radiolucency is greater than 8 mm. No restorability: Hopeless tooth. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 20 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraoral Cryotherapy<br> | Procedure: Intraoral Cryotherapy<br>* small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth<br>|
| Active Comparator: Intracanal Cryotherapy<br> | Procedure: Intracanal Cryotherapy<br>* Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed using Visual Analogue scale | Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain. | 6 hours post treatment | 
| Postoperative pain assessed using Visual Analogue scale | Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain. | 12 hours post treatment | 
| Postoperative pain assessed using Visual Analogue scale | Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain. | 24 hours post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain assessed using Visual Analogue scale | Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain. | 48 hours post treatment | 
| Postoperative pain assessed using Visual Analogue scale | Intensity of pain after root canal treatment will be recorded by the patient where 0= no pain, 1-3= mild pain, 4-6= moderate pain, 7-10= severe pain. | 72 hours post treatment |