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

NCT02273999 | Completed DMC

• 1 other identifier: 2976P
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Oral Surgery; Third Molar Extraction

Keywords

pulsed electromagnetic fields; post operative morbidity; third molar; extraction; pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog scale

  up to day 7 post intervention

Secondary Outcomes (1)

• Quality of healing

  day 7 post intervention

Study Arms (3)

Control Group (no device)

NO INTERVENTION

No devices were delivered after third molar tooth extraction

Placebo group (Inactivated device)

PLACEBO COMPARATOR

Inactivated devices were delivered after third molar tooth extraction

Device: RecoveryRx™

Test (activated device)

EXPERIMENTAL

Activated devices were delivered after third molar tooth extraction

Device: RecoveryRx™

Interventions

RecoveryRx™ DEVICE

Appliance of the device after surgery

Also known as: Pulsed electromagnetic fields

Placebo group (Inactivated device); Test (activated device)

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients who needs third molar extraction,
• good oral hygiene,
• no contraindications to treatment.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Padova, School of Dental Medicine: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Faculty department of oral surgery

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 24, 2014
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 8, 2018

Record last verified: 2018-05