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

NCT06574152 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-29

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Juliana Barros, DDS,MS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2025-06-30
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574152 on ClinicalTrials.gov