Oral Surgery, Pain, Third Molar Extraction
Conditions
Keywords
pulsed electromagnetic fields, post operative morbidity, third molar, extraction, pain
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.
Interventions
DEVICERecoveryRx™
Appliance of the device after surgery
Sponsors
University of Padova, School of Dental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog scale | up to day 7 post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of healing | 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. |
Outcome results
None listed