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Effect of Cryotherapy on Postoperative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716635
Recruitment Status : Not yet recruiting
First Posted : October 23, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Magy Essam Sayed El-Askary, Cairo University

Brief Summary:
the aim of the study is to evaluate the effect of cryotherapy on postoperative pain in molar teeth with irreversible pulpitis and apical periodontitis

Condition or disease Intervention/treatment Phase
Symptomatic Irreversible Pulpitis Procedure: cryotherapy Procedure: normal saline Not Applicable

Detailed Description:
the purpose of the study was to evaluate the effect of 2.5c cold saline irrigation as a final irrigant on postoperative pain after single visit root canal treatment of teeth with vital pulp and apical periodontitis .thirty patients will be included in the study .the teeth will be divided into 2 groups (i.e the control group and the cryotherapy group ) in the cryotherapy group ,final irrigation with 2.5c cold saline solution for 5 mins will be performed following completion of biomechanical preparation whereas in control group same solution stored at room temperature will be used . treatment will be done in a single visit then participants will be asked to rate the intensity of postoperative pain using numerical rating scale at 6,12,24,48 hrs

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

A random sequence will be generated by computer software, (http://www.random.org/).

The table will be kept with the assistant supervisor.

Masking: Single (Participant)
Masking Description: After determining the eligibility of the patient, the assistant supervisor will be contacted to assign the participant to either the intervention (cryotherapy) or the control (normal saline) groups according to the random sequence generated.
Primary Purpose: Treatment
Official Title: Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Experimental: cryotherapy
2.5c cold saline as a final flush after chemicomechanical debridement
Procedure: cryotherapy
2.5c cold saline is used as a final flush after chemomechanical preparation

normal saline
room temperature saline is used as a final flush after chemicomechanical preparation
Procedure: normal saline
a room temperature saline is used as a final flush after mechanical preparation




Primary Outcome Measures :
  1. postoperative pain assessed by NRS [ Time Frame: up to 48 hrs postoperative pain ]

    Primary outcome (post-operative pain) will be collected by the operator through (NRS) which is an 11 point scale consisting of numbers from 0 through 10 0: reading represents "no pain"

    1- 3: readings represent "mild pain" 4- 6: readings represent "moderate pain" 7- 10: readings represent "severe pain"



Secondary Outcome Measures :
  1. amount of analgesics assessed by counting [ Time Frame: up to 48 hrs postoperatively ]
    number of analgesics tablets up to 48 hrs postoperatively



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 20-40 years old.
  • 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).
  • Ability for isolation with rubberdam.
  • Restorable teeth
  • Ability to fill the root canals in single visit treatment.

Exclusion Criteria:

  • Teeth without good apical constriction, such as wide or open apex
  • Use of any type of analgesics or antibiotic medications within 3 days .Pregnant or nursing females.
  • Patients having significant systemic disorder (ASA III or IV).
  • Teeth that have :

Non vital pulp tissues. Association with swelling or fistulous tract Acute or chronic periapical abscess Greater than grade I mobility Pocket depth greater than 5 mm No possible restorability


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716635


Contacts
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Contact: magy E elaskary 01001467262 magiessam@gmail.com

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Magy Essam Sayed El-Askary, resident at endodontic department cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03716635    
Other Study ID Numbers: CEBD-CU-2018-10-19
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulpitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases