Pain Clinical Trial
Official title:
Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
This randomized clinical trial was designed to assess the clinical efficacy of Pulsed
electromagnetic field PEMF delivered with a wearable device in terms of postoperative pain
and quality of healing after mandibular third molar extraction.
The sample included 120 patients undergoing unilateral mandibular third molar extraction. The
devices were positioned over the area corresponding to the extraction site and wearers were
asked to keep them in place for 7 days. All patients were asked to record pain (on a visual
analog scale [VAS]), hours of wearing the device (groups T and P), and any use of analgesics.
At 7 days, healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain
on palpation, postoperative bleeding, alveolitis) were recorded blindly.
Introduction: Pulsed electromagnetic field (PEMF) therapy is a noninvasive method for
delivering pulsed radiofrequency energy to tissues to treat postoperative pain and edema.
This randomized clinical trial was designed to assess the clinical efficacy of PEMF delivered
with a wearable device in terms of postoperative pain and quality of healing after mandibular
third molar extraction.
Materials and methods: The sample included 120 patients undergoing unilateral mandibular
third molar extraction. At the end of the surgical procedure, patients were randomly assigned
to a test (T) or placebo (P) group and fitted with enabled or disabled PEMF devices,
respectively, or to a control (C) group not fitted with a PEMF device. The devices were
positioned over the area corresponding to the extraction site and wearers were asked to keep
them in place for 7 days. All patients were asked to record pain (on a visual analog scale
[VAS]), hours of wearing the device (groups T and P), and any use of analgesics. At 7 days,
healing complications (dehiscence, tumefaction, pus, local lymphadenopathy, pain on
palpation, postoperative bleeding, alveolitis) were recorded blindly.
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