Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924191
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-06-18
Brief Title:
Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars
Sponsor:
University of Nove de Julho
Organization:
University of Nove de Julho
Study Overview
Official Title:
Evaluation of the Preventive Effect of Photobiomodulation in the Postoperative Period of Extractions of Retained Lower Third Molars a Double-blind Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Third molar extraction is one of the most performed surgical procedures in Dentistry A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain edema and lockjaw Therefore the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molarsThe primary study variable will be postoperative edema measured in millimeters 48 hours after surgery and the secondary variables will be pain lockjaw local temperature measured with a thermographic camera dysphagia and the need to ingest nonsteroidal analgesics AcetaminophenThese variables will be evaluated at the beginning of the study baseline at 2 and 7 days post-surgery All adverse effects will be recorded The data obtained will be represented by their means SD and the p value will be set at 005
Detailed Description:
Third molar extraction is one of the most performed surgical procedures in Dentistry A comfortable postoperative period and rapid return to daily activities increase the need to control the inflammatory response and its signs and symptoms such as pain edema and lockjaw To control these events the prophylactic use of anti-inflammatory steroids has been widely recommended by some authors However there is no strong evidence on the real benefits of its use as opposed to its possible side effects Photobiomodulation has proven to be a good alternative when applied in the postoperative period to control pain edema and lockjaw On the contrary its application prior to a procedure of this type has not been sufficiently evaluated Therefore the objective of this study is to evaluate the efficacy of the prophylactic use of Photobiomodulation in the reduction of edema in the postoperative period of extractions of retained lower third molars Healthy individuals ASA I who have an indication for extraction and are included in the study will be randomly divided into two groups Control Group with the administration of prophylactic Corticosteroid Dexamethasone 8 mg 1h before surgery and the simulated application of Photobiomodulation under the same protocol as the Study Group and Study Group to which Photobiomodulation will be applied by means of intraoral Low Intensity Laser with wavelengths of 660nm and 808nm applied at 4 anatomical points power of 01W radiant exposure of 1061 Jcm2 and energy of 3J per point and an application time of 30 seconds totaling 12J of energy Besides the extraoral application will be carried out with a cluster device of combined LEDs with a total exposure area of 20cm2 which will be composed of 5 LEDs with a wavelength of 630nm power of 025W per LED a radiant exposure of 3 J cm2 and energy of 12 J per LED spot with an exposure time of 48 seconds and 4 LEDs with a wavelength of 850 nm power of 03W per LED a radiant exposure of 24 Jcm2 and an energy of 12J per LED point and an exposure time of 40 seconds The Study Group will be administered a placebo tablet simulating Dexamethasone also 1 h before the surgical procedure The primary study variable will be postoperative edema measured in millimeters 48 hours after surgery and the secondary variables will be pain lockjaw local temperature measured with a thermographic camera dysphagia and the need to ingest nonsteroidal analgesics Acetaminophen after the first 3 postoperative days where Ketorolac 10 mg will be administered orally in a regulated manner These variables will be evaluated at the beginning of the study baseline at 2 and 7 days post-surgery All adverse effects will be recorded The data obtained will be represented by their means SD and the p value will be set at 005
Keywords photobiomodulation corticosteroids extraction edema pain lockjaw quality of life randomized controlled trial
Keywords photobiomodulation corticosteroids extraction edema pain lockjaw quality of life randomized controlled trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None