Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2024
CompletedStudy Start
First participant enrolled
August 20, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedAugust 29, 2024
August 1, 2024
10 months
August 20, 2024
August 27, 2024
Conditions
Keywords
Outcome Measures
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)
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).
preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment
Study Arms (2)
EMS and PBM treatment
EXPERIMENTALPhotobiomodulation (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).
EMS and PBM sham treatment
SHAM COMPARATORThe laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation).
Interventions
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
Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana Barros, DDS,MS
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 20, 2024
First Posted
August 27, 2024
Study Start
August 20, 2024
Primary Completion
June 30, 2025
Study Completion
July 31, 2025
Last Updated
August 29, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share