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

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

Study Overview

• Status: Recruiting
• Conditions: Apical Periodontitis; Endodontic Disease; Endodontically Treated Teeth; Apical Granuloma; Apical Cyst; Periradicular Disease; Previous Endodontic Treatment
• Intervention / Treatment: Device: PBM treatment; Device: EMS; Device: PBM sham treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juliana Barros, DDS,MS; Phone Number: (713) 486-4564; Email: Juliana.Barros@uth.tmc.edu
• Study Contact Backup: Name: Kala Morales; Phone Number: 713-486-4229; Email: Kala.D.MoralesLadrondeGuevara@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Kala Morales; Phone Number: 713-486-4229; Email: Kala.D.MoralesLadrondeGuevara@uth.tmc.edu
      • Contact: Juliana Barros, DDS, MS; Phone Number: 713-486-4564; Email: Juliana.Barros@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) I or II.
• At least one tooth will receive EMS.
• Flap design that includes at least one VRI (triangular, rectangular, papilla base or submarginal rectangular).

Exclusion Criteria:

• ASA III or IV.
• Current heavy smokers (>10 cigarettes/day)
• Uncontrolled diabetes (HbA1c ≥ 7%) or other uncontrolled systemic diseases that may comprise healing, such as vitamin C deficiency, neutrophil deficiencies, immunodeficiency syndromes, or leukemia.
• Surgical access on the palatal surface.
• Acute swelling or abscess present on the day of the surgery.
• Any event or condition that would make continued participation in the study not in the best interest of the subject, as determined by the investigator.
• Pregnancy.
• Development of any medical condition that might affect the treatment and clinical outcomes, as determined by the investigator.
• Initiation of any treatment or exposure that might affect therapy's healing, as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMS and PBM treatment; Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J/cm2 (irradiation mode).	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: 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
Sham Comparator: EMS and PBM sham treatment; The laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation).	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; Device: PBM sham treatment; Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as assessed by a Visual Analogue Scale (VAS)	this is scored on a likert scale from 0(no pain), 1-3(mild pain), 4-6( moderate pain to 10(worst pain)	preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in healing as assessed by the Early Wound Healing Score (EHS).	The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI). Zero (visible distance between incision margins), 3 (incision margins in contact), or 6(merged incision margins) points were used to evaluate CSR, whereas 0 (bleeding at the incision margins), 1 (presence of fibrin at the incision margins), or 2(absence of fibrin on the incision margins) points were used for CSH and 0 points (redness involving >50% of the incision length and/or pronounced swelling) 1 point (redness involving <50% of the incision length) 2 points (absence of redness along the incision length) were used to analyze CSI The summation of the points of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points	preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Juliana Barros, DDS,MS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: laser therapy; photobiomodulation; endodontic microsurgery; vertical incision; apicoectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Lymphoproliferative Disorders; Lymphatic Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Periodontitis; Periapical Periodontitis; Granuloma; Dental Pulp Diseases; Tooth, Nonvital; Periapical Diseases
• Other Study ID Numbers: HSC-DB-24-0527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No