Recruiting

Photobiomodulation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06574152

Conditions

Apical Periodontitis

Endodontically Treated Teeth

Endodontic Disease

Apical Cyst

Apical Granuloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PBM treatment

PBM sham treatment

EMS

Study Details

Brief 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

Study ID

NCT06574152

Start date

Aug 20, 2024

Status verified date

Aug, 2026

Completion date

May 4, 2028

Anticipated

Primary completion date

May 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EMS and PBM treatment 25s group

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).

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).

experimental: EMS and PBM treatment 100s group

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 100 seconds with an energy density of 10 J/cm2 (irradiation mode).

Interventions

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

PBM sham treatment

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

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

Primary outcome measure

  • Change in pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment). ]

Central Contacts and Locations

Central contacts

Juliana Barros, DDS,MS

(713) 486-4564Juliana.Barros@uth.tmc.edu

Jennifer Tanaka, DDS

Jennifer.A.Tanaka@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Juliana Barros, DDS, MS

713-486-4564Juliana.Barros@uth.tmc.edu

Jennifer Tanaka, DDS

Jennifer.A.Tanaka@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • vertical incision
  • photobiomodulation
  • apicoectomy
  • endodontic microsurgery
  • laser therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-17.