Clinical trial NCT02273999: Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
Official title: Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Oral Surgery
Third Molar Extraction
Keywords: pulsed electromagnetic fields
post operative morbidity
third molar
extraction
pain
Lead sponsor: University of Padova, School of Dental Medicine
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients who needs third molar extraction,
* good oral hygiene,
* no contraindications to treatment.

Exclusion Criteria:

* age under 14 years;
* poor oral hygiene (plaque index less then 20%);
* contraindications for surgery (or anesthesia);
* infectious or systemic diseases;
* immunosuppressant therapy;
* pregnancy or breastfeeding;
* mental disorders.

Primary outcomes:
measure: Visual Analog scale
timeFrame: up to day 7 post intervention
Secondary outcomes:
measure: Quality of healing
timeFrame: day 7 post intervention
Other outcomes:
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