Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
Primary Purpose
Pain, Oral Surgery, Third Molar Extraction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RecoveryRx™
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Experimental
Arm Label
Control Group (no device)
Placebo group (Inactivated device)
Test (activated device)
Arm Description
No devices were delivered after third molar tooth extraction
Inactivated devices were delivered after third molar tooth extraction
Activated devices were delivered after third molar tooth extraction
Outcomes
Primary Outcome Measures
Visual Analog scale
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02273999
First Posted
October 15, 2014
Last Updated
May 2, 2018
Sponsor
University of Padova, School of Dental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02273999
Brief Title
Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
Official Title
Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Padova, School of Dental Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Oral Surgery, Third Molar Extraction
Keywords
pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group (no device)
Arm Type
No Intervention
Arm Description
No devices were delivered after third molar tooth extraction
Arm Title
Placebo group (Inactivated device)
Arm Type
Placebo Comparator
Arm Description
Inactivated devices were delivered after third molar tooth extraction
Arm Title
Test (activated device)
Arm Type
Experimental
Arm Description
Activated devices were delivered after third molar tooth extraction
Intervention Type
Device
Intervention Name(s)
RecoveryRx™
Other Intervention Name(s)
Pulsed electromagnetic fields
Intervention Description
Appliance of the device after surgery
Primary Outcome Measure Information:
Title
Visual Analog scale
Time Frame
up to day 7 post intervention
Secondary Outcome Measure Information:
Title
Quality of healing
Description
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.
Time Frame
day 7 post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Pulsed Electromagnetic Fields for Postoperative Pain: a Linical Trial in Humans
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