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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • PBM treatment

    Device

    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

  • PBM sham treatment

    Device

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

  • EMS

    Device

    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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: EMS and PBM treatment 25s groupExperimental treatment 2 interventions
Group B: EMS and PBM sham treatmentSham comparator 2 interventions
Group C: EMS and PBM treatment 100s groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).

Secondary outcomes

1

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

Time frame
preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment

Other outcomes

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