Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574152
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of Photobiomodulation PBM in postoperative pain after endodontic microsurgery EMS in patients from the University of Texas Health Science Center at Houston School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision VRI after PBM
Detailed Description:
From the University of Texas Health Science Center School of Dentistry at Houston UTHealth forty patients needing endodontic microsurgery EMS where the tissue flap design includes vertical releasing incisions will be recruited for this study
Photobiomodulation PBM has been used for decades in medicine and dentistry showing promising results in the healing capabilities however an accepted protocol has still not been created for its regular use in endodontics PBM functions on the principle of harnessing light energy to stimulate cellular activity particularly with the mitochondria Karu 2008 When specific wavelengths of light typically in the red or near-infrared spectrum penetrate the tissue a series of photochemical reactions occur This light energy enhances the production of adenosine triphosphate ATP the primary source of cellular energy leading to improved cellular function and metabolism Additionally photobiomodulation can influence various cellular processes such as reducing oxidative stress and inflammation ultimately promoting less postoperative pain and enhanced soft tissue healing Sobouti et al 2015 Fulop et al 2010 Sanz-Moliner et al 2013
Findings regarding the quality of life after apical surgery suggest that patients commonly hold negative beliefs and perceive it as one of the most painful among endodontic procedures Morse et al 1990 when in fact it could be less unpleasant than expected Iqbal et al 2007 Apical surgery has significantly evolved with the introduction of the surgical operating microscope and microsurgical instruments transforming it into a distinct and more successful procedure The adoption of microsurgical techniques has been associated with reduced postoperative pain Pecora et al 1993 likely due to minimized tissue trauma and enhanced precision facilitated by superior visualization
Consequently since PBM can promote pain relief tissue repair and regeneration it may serve as a valuable tool for EMS reducing postoperative pain and improving overall healing Mizutani et al 2016
Forty adult patients will be invited to participate in this study They will be divided into two groups A Experimental group n20 where patients will receive conventional EMS and PBM treatment and B Control group n20 where patients will receive conventional EMS and PBM sham treatment Preoperative and postoperative pain will be assessed using a visual analog pain scale and the tissue healing will be evaluated by visual inspection and photographs
Photobiomodulation PBM has been used for decades in medicine and dentistry showing promising results in the healing capabilities however an accepted protocol has still not been created for its regular use in endodontics PBM functions on the principle of harnessing light energy to stimulate cellular activity particularly with the mitochondria Karu 2008 When specific wavelengths of light typically in the red or near-infrared spectrum penetrate the tissue a series of photochemical reactions occur This light energy enhances the production of adenosine triphosphate ATP the primary source of cellular energy leading to improved cellular function and metabolism Additionally photobiomodulation can influence various cellular processes such as reducing oxidative stress and inflammation ultimately promoting less postoperative pain and enhanced soft tissue healing Sobouti et al 2015 Fulop et al 2010 Sanz-Moliner et al 2013
Findings regarding the quality of life after apical surgery suggest that patients commonly hold negative beliefs and perceive it as one of the most painful among endodontic procedures Morse et al 1990 when in fact it could be less unpleasant than expected Iqbal et al 2007 Apical surgery has significantly evolved with the introduction of the surgical operating microscope and microsurgical instruments transforming it into a distinct and more successful procedure The adoption of microsurgical techniques has been associated with reduced postoperative pain Pecora et al 1993 likely due to minimized tissue trauma and enhanced precision facilitated by superior visualization
Consequently since PBM can promote pain relief tissue repair and regeneration it may serve as a valuable tool for EMS reducing postoperative pain and improving overall healing Mizutani et al 2016
Forty adult patients will be invited to participate in this study They will be divided into two groups A Experimental group n20 where patients will receive conventional EMS and PBM treatment and B Control group n20 where patients will receive conventional EMS and PBM sham treatment Preoperative and postoperative pain will be assessed using a visual analog pain scale and the tissue healing will be evaluated by visual inspection and photographs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None