Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy

February 2, 2017 updated by: KIRIT GOLLA, Mamata Dental College

AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy.

METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth were included. The patients were assigned randomly into two groups of 20 patients each. The teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used for statistical analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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.

Study Locations

  • India
    • Telangana
      • Khammam, Telangana, India, 507002
        • Mamata Dental College

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Above 18 years of age
  • Healthy patients without any medical conditions

Exclusion Criteria:

  • root canal retreatment
  • pregnancy
  • teeth with open apices
  • a history of intolerance to nonsteroidal anti-inflammatory drugs
  • immunosuppressed patients
  • those under 18 years old
  • patients requiring antibiotic prophylaxis
  • patients with pacemakers.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cold saline
Saline stored at 4 degrees centigrade
Other: cryotherapy
Role of cryotherapy in reduction of post operative pain
Other Names:
  • Cold saline
EXPERIMENTAL: Normal Saline
Saline stored at room temperature
Other: cryotherapy
Role of cryotherapy in reduction of post operative pain
Other Names:
  • Cold saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post endodontic pain measure at different time intervals using heft parker visual analog scale
Time Frame: 12,24,48,72 hours
12,24,48,72 hours

Collaborators and Investigators

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

Sponsor

Mamata Dental College

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 (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

August 31, 2016

Study Completion (ACTUAL)

September 5, 2016

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (ESTIMATE)

February 7, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • Mamata DC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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