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

Not Applicable

Completed

• Conditions: Pain; Third Molar Extraction; Oral Surgery
• Interventions: Device: RecoveryRx™

• Registration Number: NCT02273999
• Lead Sponsor: University of Padova, School of Dental Medicine

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.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-06
• Study Completion: 2014-09
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group (Inactivated device)	RecoveryRx™	Inactivated devices were delivered after third molar tooth extraction
Test (activated device)	RecoveryRx™	Activated devices were delivered after third molar tooth extraction

Primary Outcome Measures

Name	Time	Method
Visual Analog scale	up to day 7 post intervention

Secondary Outcome Measures

Name	Time	Method
Quality of healing	day 7 post intervention	The quality of healing will be measured by scoring the presence of the following: dehiscence, tumefaction, pus, local lymphadenopathy, pain on palpation, postoperative bleeding, alveoli tis will be recorded blindly for each patients. Frequency of complications (per patients) at 7 days. Numerical values and p-values of comparisons will be recorded.