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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2018
Source University of Padova, School of Dental Medicine
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design


Intervention

Device:
RecoveryRxâ„¢
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
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