Sponsor decision

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.

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 partial or full/complete boney impacted third molars. The study group will be comprised of subjects that will receive PEMF ActiPatchTM 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 sixty (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 ActiPatch(TM) 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. This classification system is utilized in the TUSDM (Tufts University School of Dental Medicine) oral surgery clinic. 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(TM) 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.

Up to 200 subjects will be enrolled in the study to account for screen failures. Up to forty (40) subjects will be randomly assigned to each group. Recruitment will continue until up to eighty (80) subjects have qualified for study participation. This will allow for up to 25% dropout to end with 60 subjects completing the study.

The primary outcome, postoperative facial swelling at 72 hours (as measured by the 3dMD(TM)), 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. This approach will also be utilized for comparing pain (as measured by VAS). The percentage of subjects who will use rescue pain medication due to experience of postoperative pain on the group treated with PEMF ActiPatch(TM) 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. In addition, the volume measurements and the VAS scores will be analyzed using a repeated measures analysis, adjusting for subject age, gender and pain perception. Furthermore, a correlation between placebo group and the use of rescue pain medication will be determined and the association will be dictated by calculating the odds ratio. The statistical significance of this association will be examined using the Chi-square test. All p-values less than 0.025 will be considered statistically significant. Statistical analyses will be performed using SAS, Version 9.2 (SAS Institute, Cary, NC).

An initial 3dMD(TM) scan will be obtained for baseline evaluation at the extraction visit. A second 3dMD(TM) scan will be obtained for evaluation and determination of facial swelling at the 72 hour follow up visit. A third scan will be obtained at the 10 day follow up visit to evaluate the degree of resolution of swelling. The scan will result in a computer-generated image, on which the investigator will outline the area of clinical interest and calculate the volume using integration. The process of surface scanning and volume measurement will use the 3dMD(TM) Vultus software® (3dMD(TM), Atlanta, Georgia, United States).The Vultus software allows for pre and post-surgery superimposition of images as well as quantitative evaluation of surface and volume changes. The PI has had on site training at the Georgia 3dMD facility and had additional training when the camera array was installed. The technique of obtaining the image is straight forward and there is a set of instructions at the installation site for immediate review as necessary. The PI and a representative from 3dMD company will give training to the co-investigators who will be using the device.

The degree of facial swelling between the two groups at the two time points (72 hour follow up and 10 day follow up) will be compared using the data collected from 3dMD(TM). Furthermore, the change in volume between the two scans taken at the 72 hour follow up visit and the 10 day follow up within each group will also be compared. The volumetric difference between the two groups will be analyzed for any statistical significance.

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.

study terminated prior to being conducted

study terminated prior to being conducted

study terminated prior to being conducted