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Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans

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ClinicalTrials.gov Identifier: NCT02273999
Recruitment Status : Completed
First Posted : October 24, 2014
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Stefano Sivolella, University of Padova, School of Dental Medicine

Brief Summary:

This randomized clinical trial was designed to assess the clinical efficacy of Pulsed electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

The sample included 120 patients undergoing unilateral mandibular third molar extraction. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.


Condition or disease Intervention/treatment Phase
Pain Oral Surgery Third Molar Extraction Device: RecoveryRx™ Not Applicable

Detailed Description:

Introduction: Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema. This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered with a wearable device in terms of postoperative pain and quality of healing after mandibular third molar extraction.

Materials and methods: The sample included 120 patients undergoing unilateral mandibular third molar extraction. At the end of the surgical procedure, patients were randomly assigned to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices, respectively, or to a control (C) group not fitted with a PEMF device. The devices were positioned over the area corresponding to the extraction site and wearers were asked to keep them in place for 7 days. All patients were asked to record pain (on a visual analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveolitis) were recorded blindly.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
Study Start Date : September 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group (no device)
No devices were delivered after third molar tooth extraction
Placebo Comparator: Placebo group (Inactivated device)
Inactivated devices were delivered after third molar tooth extraction
Device: RecoveryRx™
Appliance of the device after surgery
Other Name: Pulsed electromagnetic fields

Experimental: Test (activated device)
Activated devices were delivered after third molar tooth extraction
Device: RecoveryRx™
Appliance of the device after surgery
Other Name: Pulsed electromagnetic fields




Primary Outcome Measures :
  1. Visual Analog scale [ Time Frame: up to day 7 post intervention ]

Secondary Outcome Measures :
  1. Quality of healing [ Time Frame: day 7 post intervention ]
    The quality of healing will be measured by scoring the presence of the following: dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveoli tis will be recorded blindly for each patients. Frequency of complications (per patients) at 7 days. Numerical values and p-values of comparisons will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients who needs third molar extraction,
  • good oral hygiene,
  • no contraindications to treatment.

Exclusion Criteria:

  • age under 14 years;
  • poor oral hygiene (plaque index less then 20%);
  • contraindications for surgery (or anesthesia);
  • infectious or systemic diseases;
  • immunosuppressant therapy;
  • pregnancy or breastfeeding;
  • mental disorders.

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Responsible Party: Stefano Sivolella, Clinical Faculty department of oral surgery, University of Padova, School of Dental Medicine
ClinicalTrials.gov Identifier: NCT02273999    
Other Study ID Numbers: 2976P
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Stefano Sivolella, University of Padova, School of Dental Medicine:
pulsed electromagnetic fields
post operative morbidity
third molar
extraction
pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms