About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
PBM treatment
DeviceImmediately 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
PBM sham treatment
DeviceImmediately after the apical microsurgery, sham therapy will be performed without activating the laser.
EMS
DevicePatients 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
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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
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