Third Molar Extraction and Pulsed Electromagnetic FieldTherapy

NCT02376946 | Terminated Results

• 1 other identifier: 10436
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Edema and Pain

Outcome Measures

Primary Outcomes (1)

• Change in Postoperative Facial Swelling

  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.

  72 Hours post surgery and 10 days post surgery

Study Arms (2)

Actipatch

ACTIVE COMPARATOR

The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.

Device: ActiPatch(TM)

Placebo

PLACEBO COMPARATOR

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

Interventions

ActiPatch(TM) DEVICE

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.

Also known as: ActiBand(TM)

Actipatch

Placebo DEVICE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• 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
• 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
• Subjects must be physically able to tolerate conventional surgical procedures (ASA I/II)
• Subjects must agree to follow the study protocol.

You may not qualify if:

• 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.
• Subjects with a cardiac pacemaker, cardioverter defibrillator, neurostimulator or any active medical or metallic implant (including dental implant).
• Subjects with skeletal immaturity.
• Subjects with self-reported current or history of substance abuse.
• Subjects who are currently receiving any anti-inflammatory or pain medication chronically or they suffer from a chronic pain condition.
• Subjects with an allergy to vicodin (or its constituents, acetaminophen and hydrocodone).
• Subjects who are diagnosed with fibromyalgia.

Sponsors & Collaborators

• Tufts University: lead
• BioElectronics Corporation: collaborator

Study Sites (1)

Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery

Boston, Massachusetts, 02111, United States

Location

Related Publications (10)

• Little RC, Ginsburg JM. The physiologic basis for clinical edema. Arch Intern Med. 1984 Aug;144(8):1661-4. doi: 10.1001/archinte.144.8.1661.

  PMID: 6466021 BACKGROUND

• Conrad SM, Blakey GH, Shugars DA, Marciani RD, Phillips C, White RP Jr. Patients' perception of recovery after third molar surgery. J Oral Maxillofac Surg. 1999 Nov;57(11):1288-94; discussion 1295-6. doi: 10.1016/s0278-2391(99)90861-3.

  PMID: 10555792 BACKGROUND

• van Gool AV, Ten Bosch JJ, Boering G. Clinical consequences of complaints and complications after removal of the mandibular third molar. Int J Oral Surg. 1977 Feb;6(1):29-37. doi: 10.1016/s0300-9785(77)80069-0.

  PMID: 402320 BACKGROUND

• Zuniga JR, Phillips CL, Shugars D, Lyon JA, Peroutka SJ, Swarbrick J, Bon C. Analgesic safety and efficacy of diclofenac sodium softgels on postoperative third molar extraction pain. J Oral Maxillofac Surg. 2004 Jul;62(7):806-15. doi: 10.1016/j.joms.2003.12.019.

  PMID: 15218558 BACKGROUND

• Urquhart E. Analgesic agents and strategies in the dental pain model. J Dent. 1994 Dec;22(6):336-41. doi: 10.1016/0300-5712(94)90084-1.

  PMID: 7844260 BACKGROUND

• Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.

  PMID: 12148679 BACKGROUND

• Troullos ES, Hargreaves KM, Butler DP, Dionne RA. Comparison of nonsteroidal anti-inflammatory drugs, ibuprofen and flurbiprofen, with methylprednisolone and placebo for acute pain, swelling, and trismus. J Oral Maxillofac Surg. 1990 Sep;48(9):945-52. doi: 10.1016/0278-2391(90)90007-o.

  PMID: 2395047 BACKGROUND

• Schultze-Mosgau S, Schmelzeisen R, Frolich JC, Schmele H. Use of ibuprofen and methylprednisolone for the prevention of pain and swelling after removal of impacted third molars. J Oral Maxillofac Surg. 1995 Jan;53(1):2-7; discussion 7-8. doi: 10.1016/0278-2391(95)90486-7.

  PMID: 7799116 BACKGROUND

• Ganzber S. Analgesics: opioids and nonopioids. In: Ciancio S, ed. ADA guide to dental therapeutics. Chicago: ADA Publishing; 1998:80-107.

  BACKGROUND

• Dionne RA, Gordon SM. Nonsteroidal anti-inflammatory drugs for acute pain control. Dent Clin North Am. 1994 Oct;38(4):645-67.

  PMID: 7805940 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Archana Viswanath
• Organization: TuftsU

Archana.Viswanath@tufts.edu

617-636-3578

Study Officials

• Archana Viswanath

  Research Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Locations

US (1)