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

Pain Clinical Trial

Official title:

Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02273999
• Other study ID #: 2976P
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2018
• Source: University of Padova, School of Dental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Oral Surgery
• Pain
• Pain, Postoperative
• Third Molar Extraction

Intervention

Device:
• RecoveryRx™
Appliance of the device after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova, School of Dental Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog scale		up to day 7 post intervention
Secondary	Quality of healing	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.	day 7 post intervention