The Effect of Intra Oral Cryotherapy in Patients With Symptomatic Apical Periodontitis

Study Overview
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Brief Summary
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The participants were divided into two groups: Group I (cryotherapy) (n =10) after the completion of the mechanical preparation intra oral cryotherapy was applied. Group II (control) (n =10) received standard root canal treatment without the application of any type of cryotherapy.

Detailed Description
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1-Patients selection: 20 patients with symptomatic apical peridontitis related to mandibular premolars were selected . After proper anestehsia, Access cavity preparation was performed. The working length measured using apex locator. chemicomechanical preparation was done. for cryotherapy group: cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth for a total time of 30 minutes. apical fluid sample was collected by paper point and the root canal was then filled using gutta percha and resin-based sealer.The access cavity was sealed using glass ionomer restoration. for the control group normal treatment was done and apical fluid was collested also before obturation.

Official Title
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The Effect of Intra Oral Cryotherapy on Post Operative Pain and the Level ofSubstancs P in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Conditions
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Inflammation, Post Operative Pain

Intervention / Treatment
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* Procedure: intraoral cryotherapy,ice gel


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: clinical diagnosis of symptomatic apical periodontitis related to ving a mandibular single-rooted premolars radigraphically: absence of periapical radiolucency on x ray. Exclusion criteria: The presence of any systemic disease or allergic reactions Vulnerable population: prisoners, pregnant women, mentally ill people, etc. Use of analgesic or antibiotic medication within three days A radiographically untraceable canal

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>no application of any type of cryotherapy. | |
| Active Comparator: cryotherapy group<br>after the completion of the mechanical preparation. A 2.5 x5 centimetre gel pack was placed in the mouth on the vestibular surface of the treated tooth. | Procedure: intraoral cryotherapy,ice gel<br>* A cold pack (ice gel enveloped by a sealed plastic cover) measuring 2.5 x 5 centimetres was placed intraorally on the vestibular surface of the treated tooth. Each cold pack was kept for ten minutes.3 packs were used for each patient, for a total time of 30 minutes.Patients were instructed to remove the cold pack for 1-2 minutes if they felt extreme cold or a burning sensation .The temperature of the gel was checked by a digital thermometer (Brannan, UK) after it was removed from the freezer and kept in an ice box (Cosmoplast, UAE) containing a cooling gel (Exam Packaging, Belgium).<br>* Other names: cold therapy,ice pack;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of post operative pain using 10 cm visual analoge scale (VAS) | On a10-cm Visual Analogue Scale (VAS) questionnaire, each patient reported their level of pain as follows: There is no pain at 0, 1-3, mild, 4-6, moderate, 7-9, severe, and 10, the worst pain. | after 6hours, 24hours, 48hours, 72hours h, and 7days after the visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of inflammatory mediator substance P in apical fluid | Apical fluid samples were obtained using paper points size 25 passing 2 mm beyond the apex.where they were soaked by the periapical interstitial fluid for 1 minute .Four mm from the tip of each paper point was cut and dropped into 1.5-mL Eppendorf tubes (Swanscombe, UK) with 1 mL (pH 7.4) phosphate buffered saline, then stored at -80°C. Levels of substance p were measured using the ELISAtest. | base line: immediately after procedure.the second is 30 minutes later in both groups. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryotherapy, substance P, apical periodontitis, post operative pain