NCT06574152

Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery

Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (n=20) where patients will receive conventional EMS and PBM treatment, and (B) Control group (n=20) 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.

Conditions

• Apical Periodontitis
• Endodontically Treated Teeth
• Endodontic Disease
• Apical Cyst
• Apical Granuloma
• Periradicular Disease
• Previous Endodontic Treatment

Interventions

Type	Name	Description
DEVICE	PBM treatment	Immediately after the apical microsurgery, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA), with an 8 mm tip diameter . The laser tip will be placed following the outline of the incision flap in a contact mode . The power output of the laser will be 50 milliwatt (mW) and verified by a Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2
DEVICE	PBM sham treatment	Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.
DEVICE	EMS	Patients will be anesthetized. All surgeries will be performed using a surgical microscope. After reflection of a mucoperiosteal flap, osteotomies will be performed to access the root apices and apical lesions. Root apices will be resected at 3 mm, and the pathological tissue curetted out. Next, root-end preparations will be made with ultrasonic tips and filled with calcium silicate-based materials. Methylene blue dye will be used for inspection after root-end resection before the root-end preparation and filling. After cleaning the osseous crypt, the wound margins will be reapproximated with 5-0 single interrupted sutures. A gauze will be placed for 30 minutes for wound compression. Sutures will be removed seven days postoperatively

Timeline

• Start date: 2024-08-20
• Primary completion: 2025-06-30
• Completion: 2025-07-31
• First posted: 2024-08-27
• Last updated: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study