Trial Outcomes & Findings for Third Molar Extraction and Pulsed Electromagnetic FieldTherapy (NCT NCT02376946)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

72 Hours post surgery and 10 days post surgery

Results posted on

2021-11-01

Participant Flow

Participant milestones

Participant milestones
Measure	Actipatch The study group will be comprised of subjects that will receive PEMF ActiPatchTM treatment for postoperative management of pain and edema. 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.	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. 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.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Third Molar Extraction and Pulsed Electromagnetic FieldTherapy

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 72 Hours post surgery and 10 days post surgery

Population: study terminated prior to being conducted

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.

Outcome measures

Outcome data not reported

Adverse Events

Actipatch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Archana Viswanath

TuftsU

Phone: 617-636-3578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place