Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Study Overview
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Brief Summary
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Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis . a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.

Detailed Description
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PICO/ Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication. Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain. Sequence of Procedural steps: Full medical and dental history will be obtained from all the patients . Thorough clinical and radiographic examination for the tooth to be treated will be done. The tooth will be anaesthetized and Access cavity will be performed. The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument. Canals will be dried using sterile paper points. In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C. In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment. In the control group, final irrigation will be done using normal saline at room temperature. Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer. The access cavity will then be closed with temporary filling. Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.

Official Title
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Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Other: cold saline (cryotherapy)
* Drug: Ibuprofen 400 mg
* Other: Final irrigation with normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients above 18 years old and to 60. Male or female. Patients seeking root canal treatment. Molar teeth with Symptomatic irreversible pulpitis with preoperative sharp, moderate, or severe pain with normal periapical radiographic appearance or slight widening in lamina dura. Systematically healthy patient (ASA I). Patient who can understand VAS and sign informed consent. Exclusion Criteria: Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV). History of intolerance to NSAIDS. Patients with two or more adjacent teeth requiring endodontic treatment. External root resorption. Internal root resorption. Vertical root fracture. Periapical lesion. Pregnancy. Use of ibuprofen in the last 12 hour. Bleeding disorder. Long term corticosteroid use. 10 Mobility Grade II or III. Pocket depth more than 5mm. Previous root canal therapy. Non-restorability. TMJ problems, bruxism, clenching or traumatic occlusion. Inability to perceive the given instructions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Final irrigation with cold saline (cryotherapy).<br>20ml of 2.5°C cold saline for 5 min | Other: cold saline (cryotherapy)<br>* using 20ml of 2.5°C cold saline for 5 min<br>|
| Experimental: Ibuprofen post-operative medication.<br>a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment | Drug: Ibuprofen 400 mg<br>* patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.<br>|
| Active Comparator: Final irrigation with normal saline, and no post-operative medication<br>final irrigation will be done using normal saline at room temperature. | Other: Final irrigation with normal saline<br>* final irrigation will be done using normal saline at room temperature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | The pain will be recorded using the modified visual analogue scale (VAS). • 0, no pain 1-3, mild pain 4-6, moderate pain 7-10, severe pain 10 being the most intense pain conceivable. | 6 hours post-operatively | 
| Post-operative pain | The pain will be recorded using the modified visual analogue scale (VAS). • 0, no pain 1-3, mild pain 4-6, moderate pain 7-10, severe pain 10 being the most intense pain conceivable. | 24 hours post-operatively | 
| Post-operative pain | The pain will be recorded using the modified visual analogue scale (VAS). • 0, no pain 1-3, mild pain 4-6, moderate pain 7-10, severe pain 10 being the most intense pain conceivable. | 48 hours post-operatively |