CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
oral Cryotherapy +2 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07138365
NCT07138365N/ACompleted

Clinical and Biochemical Effects Of Different Cryotherapy Protocols On Endodontic Treated Mandibular Premolars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial

Ain Shams University·interventional·Posted Aug 22, 2025·Updated Feb 11, 2026

In Brief

A clinical study evaluating oral Cryotherapy, Intra radicular Cryotherapy, and 1 other intervention for Post Operative Pain and Inflammation. Completed, enrolled 180 participants across 1 site.

Detailed Summary

Pain is the major reason for patients' visits to dental clinics.Medications have side effects. Treatments including cryotherapy have been suggested to prevent these side effects.This study will compare the effect of oral and intraradicular cryotherapy on the level of substance p ,post operative pain and analgesic intake in mandibular premolars with symptomatic apical periodontitis. Thirty patients with symptomatic apical periodontitis will be randomly distributed into three groups: oral,intraradicular cryotherapy and control group (n = 10). In the oral cryotherapy group application of (a cold pack of ice gel enveloped by a sealed plastic cover) will be performed for 30 minutes following the completion of canal preparation.Getting glide path by inserting K-file #10. coronal flaring will be done .The first apical fluid samples for all groups will be obtained at this step. Intra-radicular cryotherapy will be performed where normal root canal treatment will be done. Then a final flush will be done with 20 mL of cold saline 2.5°C for 10 minutes. For the control group,no application of cryotherapy will be done.Second samples will be taken after mechanical preparation for intraradicular and control ,and after 30minutes of cold application for the cryotherapy group.Levels of substance p will be measured using the ELISA test.The patients will be asked to fill out the VAS questionnaire at 6, 24, 48 and 72 h.and analgesic intake

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedAug 22, 2025
Enrollment StartJun 1, 2024
Primary CompletionJun 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10 months ago

Interventions

oral Cryotherapyprocedure

custom made plastic pack measuring 2.5 X5 cm containing ice gel will be placed intraorally in the mouth on the vestibular surface of the treated tooth.

Intra radicular Cryotherapyprocedure

Final flush was done with cold (2-4 oC) Saline for 10 mins.

cold irrigationprocedure

irrigation with cold (2-4 oC) 2.5% NaOCl and Final flush was done with cold (2-4 oC) Saline for 10 mins.