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Third Molar Extraction and Pulsed Electromagnetic FieldTherapy

NCT02376946 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-11-01

Study results available
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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

Interventions

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.

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.

Sponsors & Collaborators

  • BioElectronics Corporation

    collaborator INDUSTRY

  • Tufts University

    lead OTHER

Principal Investigators

  • Archana Viswanath · Research Professor

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376946 on ClinicalTrials.gov