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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | no application of any type of cryotherapy. | |
| cryotherapy group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoral cryotherapy,ice gel | Procedure | 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). |
| 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maram F Obeid, Professor | Faculty of Dentistry,Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29398090 | Background | Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3. | |
| 37222468 | Background | Keskin C, Aksoy A, Kalyoncuoglu E, Keles A, Ilik AA, Komec O, Yuzgulec E, Akgun H, Alak SG, Tokur O. Effect of intracanal cryotherapy on the inflammatory cytokine, proteolytic enzyme levels and post-operative pain in teeth with asymptomatic apical periodontitis: A randomized clinical trial. Int Endod J. 2023 Aug;56(8):932-942. doi: 10.1111/iej.13937. Epub 2023 May 30. |
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detailed Statistical Analysis Plan
2025 ,available for a year
review the purpose of request
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007249 | Inflammation |
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This study was designed to be a randomized, controlled, single-blinded, single-center clinical trial.
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A) Sequence generation;was done using a random sequence number generated by computer software.
B) Allocation Concealment Mechanism: Folded, numbered papers were placed in tightly sealed envelopes containing the patient's coding
|
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| base line: immediately after procedure.the second is 30 minutes later in both groups. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |