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Completed

NCT Number: NCT02273999

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

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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Key information

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RecoveryRx™

Device

Appliance of the device after surgery

Other names: Pulsed electromagnetic fields

Primary outcomes

  1. Visual Analog scale

    Time frame: up to day 7 post intervention

Secondary outcomes

  1. Quality of healing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Padova, School of Dental Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2014
Registry last updated
May 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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