Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Oral Surgery Third Molar Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group (no device)

No devices were delivered after third molar tooth extraction

Group Type NO_INTERVENTION

No interventions assigned to this group

Placebo group (Inactivated device)

Inactivated devices were delivered after third molar tooth extraction

Group Type PLACEBO_COMPARATOR

RecoveryRx™

Intervention Type DEVICE

Appliance of the device after surgery

Test (activated device)

Activated devices were delivered after third molar tooth extraction

Group Type EXPERIMENTAL

RecoveryRx™

Intervention Type DEVICE

Appliance of the device after surgery

Interventions

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RecoveryRx™

Appliance of the device after surgery

Intervention Type DEVICE

Other Intervention Names

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Pulsed electromagnetic fields

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes