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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044470
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
KIRIT GOLLA, Mamata Dental College

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Effects of; Cold Other: cryotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : August 31, 2016
Actual Study Completion Date : September 5, 2016

Arm Intervention/treatment
Experimental: Cold saline
Saline stored at 4 degrees centigrade
Other: cryotherapy
Role of cryotherapy in reduction of post operative pain
Other Name: Cold saline

Experimental: Normal Saline
Saline stored at room temperature
Other: cryotherapy
Role of cryotherapy in reduction of post operative pain
Other Name: Cold saline




Primary Outcome Measures :
  1. Post endodontic pain measure at different time intervals using heft parker visual analog scale [ Time Frame: 12,24,48,72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03044470


Locations
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India
Mamata Dental College
Khammam, Telangana, India, 507002
Sponsors and Collaborators
Mamata Dental College

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Responsible Party: KIRIT GOLLA, POST GRADUATE, Mamata Dental College
ClinicalTrials.gov Identifier: NCT03044470    
Other Study ID Numbers: Mamata DC
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No