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EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cold application
Sponsored by
Baskent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impacted Third Molar Tooth focused on measuring Ice pack therapy, third molar surgery, swelling, pain, trismus

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cold application

    No Cold application

    Arm Description

    Cold applied after extraction of third molar tooth.

    Cold application is not advised after extraction of third molar tooth

    Outcomes

    Primary Outcome Measures

    Post operative Visual Analogue Scale Scores
    Post operative facial swelling
    Post-operative mouth opening

    Secondary Outcome Measures

    Complications after impacted third molar removal

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    August 23, 2017
    Sponsor
    Baskent University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03261869
    Brief Title
    EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY
    Official Title
    EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY: A RANDOMIZED CONTROLLED CLINICAL TRIAL
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    March 1, 2017 (Actual)
    Study Completion Date
    March 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Baskent University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impacted Third Molar Tooth
    Keywords
    Ice pack therapy, third molar surgery, swelling, pain, trismus

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cold application
    Arm Type
    Experimental
    Arm Description
    Cold applied after extraction of third molar tooth.
    Arm Title
    No Cold application
    Arm Type
    No Intervention
    Arm Description
    Cold application is not advised after extraction of third molar tooth
    Intervention Type
    Other
    Intervention Name(s)
    Cold application
    Primary Outcome Measure Information:
    Title
    Post operative Visual Analogue Scale Scores
    Time Frame
    pre-operative-postoperative 7th day
    Title
    Post operative facial swelling
    Time Frame
    pre-operative-postoperative 7th day
    Title
    Post-operative mouth opening
    Time Frame
    pre-operative-postoperative 7th day
    Secondary Outcome Measure Information:
    Title
    Complications after impacted third molar removal
    Time Frame
    pre-operative-postoperative 7th day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY

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