EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY

EFFICACY OF ICE PACK THERAPY AFTER IMPACTED THIRD MOLAR SURGERY: A RANDOMIZED CONTROLLED CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Other: Cold application

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post operative Visual Analogue Scale Scores	pre-operative-postoperative 7th day
Post operative facial swelling	pre-operative-postoperative 7th day
Post-operative mouth opening	pre-operative-postoperative 7th day

Secondary Outcome Measures

Outcome Measure	Time Frame
Complications after impacted third molar removal	pre-operative-postoperative 7th day

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Ice pack therapy, third molar surgery, swelling, pain, trismus
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: D-KA 15/07

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