RecruitingNot ApplicableNCT06574152

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

40 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

DEVICEPBM 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

DEVICEPBM sham treatment

Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.

DEVICEEMS

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


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06574152