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Third Molar Extraction and Pulsed Electromagnetic FieldTherapy (PEMF)

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: NCT02376946
Recruitment Status : Terminated (Sponsor decision)
First Posted : March 3, 2015
Last Update Posted : January 20, 2017
Sponsor:
Collaborator:
BioElectronics Corporation
Information provided by (Responsible Party):
Tufts University School of Dental Medicine

Brief Summary:

This study is a prospective, randomized, double-blinded, controlled, clinical trial that evaluates the efficacy of using PEMF in the postoperative period in decreasing swelling and pain after extraction of impacted third molars. The study group will be comprised of subjects that will receive PEMF Actiband treatment for postoperative management of pain and edema. The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.

Thirty (30) subjects will be randomly assigned to each group. Enrollment will continue until 60 qualified subjects have been recruited. Eligibility criteria will be based on the standards for conducting oral surgery procedures on third molar extractions, in addition to safety considerations and contraindications for the Actiband and other agents to be used. Moreover, the selected subjects will have the same surgical difficulty and surgical trauma anticipated standardized by classification system of impacted third molars. All inclusion and exclusion criteria will be thoroughly explained in the relevant section of this proposal. Postoperative edema and pain will be evaluated using 3dMD and Visual Analog Scale, respectively. Different measurements will be obtained immediately before the surgery and in standard periodic intervals as described in the Materials and Methods section of the proposal. Any difference in postoperative edema, pain, and site responsible for request of rescue pain medication will be compared and analyzed between the two groups.


Condition or disease Intervention/treatment Phase
Postoperative Edema and Pain Device: ActiPatch(TM) Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Evaluation of Postoperative Edema and Pain Following Third Molar Extraction With Application of Pulsed Electromagnetic Field (PEMF) Therapy
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Actipatch
The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.
Device: ActiPatch(TM)
Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema.
Other Name: ActiBand(TM)

Placebo Comparator: Placebo
The control group will be comprised of the subjects that will receive a placebo patch as treatment for postoperative management of pain and edema.
Device: Placebo
Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema.




Primary Outcome Measures :
  1. Change in Postoperative Facial Swelling [ Time Frame: 72 Hours post surgery and 10 days post surgery ]
    The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMDTM), will be compared between the two groups using independent sample t-test if the data are normally distributed, or the Mann Whitney U test if non-parametric methods need to be utilized.


Secondary Outcome Measures :
  1. Change in Pain Levels [ Time Frame: 72 Hours post surgery and 10 days post surgery ]
    The percentage of subjects who will use rescue pain medication due to experience of postoperative pain on the group treated with PEMF ActiPatchTM will be compared with the percentage of subjects who will use rescue pain medication due to experience of postoperative pain for the group received placebo, using a Chi-square test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Subjects of either sex and of any race between the ages of 18 and 30 years. 30 Years old is the upper age limit because wisdom teeth extraction is normally done between the ages of 18 and 30, since after the age of 30 additional complications can arise during surgeries.
  2. Subjects for whom a decision has been made to extract 2 to 4 third molars. At least two must be classified as full or partially bony impacted (as defined below) of any angulation under local anesthesia alone, local anesthesia and sedation or local anesthesia and general anesthesia all in an outpatient setting.

    1. Full/complete bony: The entire tooth is below the level of the alveolar bone. The tooth is completely encased in bone so that when the gingiva is cut and reflected back, the tooth is not seen. Bone removal (large amounts) together with root sectioning will be needed to remove the tooth.33
    2. Partial bony: A portion of the height of the contour of the tooth is below the level of the alveolar bone. The superficial portion of the tooth is covered only by soft tissue but the height of the tooth's contour is below the level of the surrounding alveolar bone.33
  3. Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)
  4. Subjects must agree to follow the study protocol.

Exclusion Criteria:

  1. Subjects who are known to be pregnant or think they may be pregnant. (A urine pregnancy test will be performed on female subjects at Day 0 - Visit 1. Subjects testing positive will be excluded from study participation.
  2. Subjects with a cardiac pacemaker, cardioverter defibrillator, neurostimulator or any active medical or metallic implant (including dental implant).
  3. Subjects with skeletal immaturity.
  4. Subjects with self-reported current or history of substance abuse.
  5. Subjects who are currently receiving any anti-inflammatory or pain medication chronically or they suffer from a chronic pain condition.
  6. Subjects with an allergy to vicodin (or its constituents, acetaminophen and hydrocodone).
  7. Subjects who are diagnosed with fibromyalgia.

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): NCT02376946


Locations
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United States, Massachusetts
Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University School of Dental Medicine
BioElectronics Corporation
Publications:
Ganzber S. Analgesics: opioids and nonopioids. In: Ciancio S, ed. ADA guide to dental therapeutics. Chicago: ADA Publishing; 1998:80-107.

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Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT02376946    
Other Study ID Numbers: 10436
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Edema
Signs and Symptoms