NCT06574152 · The University of Texas Health Science Center, Houston
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
What this study is about
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
View original scientific description
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
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
Primary outcome measures
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).
this is scored on a likert scale from 0(no pain), 1-3(mild pain), 4-6( moderate pain to 10(worst pain)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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.
Where
- Houston, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations