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

University of Padova, School of Dental Medicine

Status: Completed

Conditions: Oral Surgery; Third Molar Extraction; Pain

Treatments: Device: RecoveryRx™

Study type: Interventional

Funder types: Other

Identifiers

NCT02273999

2976P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Control Group (no device)

No Intervention group

Description:

No devices were delivered after third molar tooth extraction

Placebo group (Inactivated device)

Placebo Comparator group

Description:

Inactivated devices were delivered after third molar tooth extraction

Treatment:

Device: RecoveryRx™

Test (activated device)

Experimental group

Description:

Activated devices were delivered after third molar tooth extraction

Treatment:

Device: RecoveryRx™