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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. Identifier: NCT03261869
Recruitment Status : Completed
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Nurettin Diker, Baskent University

Brief Summary:
this study evaluates the effect of cold application after impacted third molar extractions. Patients have bilateral impacted third molar tooth included in this study. Patients do not applied cold after extraction of third molar on one side and applied cold cold after extraction of third molar on the other side.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Other: Cold application Not Applicable

Detailed Description:

Extraction of impacted teeth causes a trauma which results in an inflammatory response. Some postoperative symptoms may occur such as edema, pain, limitations in mouth opening and dysfunction as a consequence of the wisdom tooth extraction surgery.

Local cold application reduces the magnitude of postoperative symptoms. The physiological effects of cold application are as follows: vasoconstriction of blood vessels, blood flow to the region decreases, edema and inflammation decreases, slowdown in cell metabolism and a decrease in local oxygen demand due to the vasoconstriction effect of the cold. Cold therapy also induces muscle constriction which reduces muscle stress, pain and inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Arm Intervention/treatment
Experimental: Cold application
Cold applied after extraction of third molar tooth.
Other: Cold application
No Intervention: No Cold application
Cold application is not advised after extraction of third molar tooth

Primary Outcome Measures :
  1. Post operative Visual Analogue Scale Scores [ Time Frame: pre-operative-postoperative 7th day ]
  2. Post operative facial swelling [ Time Frame: pre-operative-postoperative 7th day ]
  3. Post-operative mouth opening [ Time Frame: pre-operative-postoperative 7th day ]

Secondary Outcome Measures :
  1. Complications after impacted third molar removal [ Time Frame: pre-operative-postoperative 7th day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Bilateral bony mandibular third molar impactions
  • Has no systemic disease

Exclusion Criteria:

  • Different Pell-Gregory classification of impacted teeth
  • Previous or current gastric ulcer
  • Allergies or hypersensitivities to any common medications
  • pregnant or breastfeeding patients
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Responsible Party: Nurettin Diker, Research Assistant at deparment of oral and maxillofacial surgery, Baskent University Identifier: NCT03261869    
Other Study ID Numbers: D-KA 15/07
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
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
Keywords provided by Nurettin Diker, Baskent University:
Ice pack therapy, third molar surgery, swelling, pain, trismus
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases