Pain Clinical Trial
Official title:
Pulsed Electromagnetic Fields for Postoperative Pain: a Randomized Controlled Clinical Trial in Patients Undergoing Mandibular Third Molar Extraction
NCT number | NCT02273999 |
Other study ID # | 2976P |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | September 2014 |
Verified date | May 2018 |
Source | University of Padova, School of Dental Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Padova, School of Dental Medicine |
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 |
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