Effect of Cryotherapy on Postoperative Pain

October 22, 2018 updated by: Magy Essam Sayed El-Askary, Cairo University

Effect of Intracanal Cryotherapy on Postoperative Pain in Molar Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
up to 48 hrs postoperative pain

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amount of analgesics assessed by counting
Time Frame: up to 48 hrs postoperatively
number of analgesics tablets up to 48 hrs postoperatively
up to 48 hrs postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2018

Primary Completion (ANTICIPATED)

November 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

October 20, 2018

First Submitted That Met QC Criteria

October 20, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEBD-CU-2018-10-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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