Third Molar Extraction and Pulsed Electromagnetic FieldTherapy (PEMF)
|ClinicalTrials.gov Identifier: NCT02376946|
Recruitment Status : Terminated (Sponsor decision)
First Posted : March 3, 2015
Last Update Posted : January 20, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Active Comparator: Actipatch
The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema.
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.
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376946
|United States, Massachusetts|
|Tufts University School of Dental Medicine Department of Oral and Maxillofacial Surgery|
|Boston, Massachusetts, United States, 02111|