Actively Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery: A Randomized Clinical Trial
Led by The University of Texas Health Science Center, Houston · Updated on 2024-08-29
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of Photobiomodulation (PBM) therapy on postoperative pain and healing after endodontic microsurgery (EMS) in adults. The study focuses on patients undergoing EMS with vertical releasing incisions (VRI) and aims to assess how PBM affects pain relief and soft tissue healing. This study is conducted by the University of Texas Health Science Center at Houston and explores a promising light-based therapy that stimulates cellular activity to improve healing and reduce inflammation. Forty adult patients will be divided into two groups: one receiving conventional EMS plus PBM treatment using a 660 nm diode laser applied to the incision area, and the other receiving conventional EMS plus a sham PBM treatment without laser activation. EMS procedures involve anesthesia, microscopic surgical techniques, root-end resection, and suturing. PBM therapy is applied immediately after surgery by irradiating the incision site for 25 seconds at a specific energy density. The control group undergoes the same EMS but with sham laser treatment. Participants will have pain levels measured by a visual analog scale before surgery, on the day of surgery, and 5 to 7 days after surgery at suture removal. Healing will be evaluated using the Early Wound Healing Score at baseline, immediately post-surgery, and during suture removal. Photos and visual inspections will track soft tissue recovery. The entire study monitors postoperative pain and tissue healing to understand PBM's effects after EMS, with participation lasting through the suture removal period about a week later.
CONDITIONS
Brief Title
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists (ASA) health status I or II
- At least one tooth scheduled for endodontic microsurgery (EMS)
- Flap design includes at least one vertical releasing incision (VRI) such as triangular, rectangular, papilla base, or submarginal rectangular incision
- Adults aged 18 years or older
You will not qualify if you...
- American Society of Anesthesiologists (ASA) health status III or IV
- Current heavy smokers (more than 10 cigarettes per day)
- Uncontrolled diabetes (HbA1c ≥ 7%) or other uncontrolled systemic diseases affecting healing such as vitamin C deficiency, neutrophil deficiencies, immunodeficiency syndromes, or leukemia
- Surgical access on the palatal surface
- Presence of acute swelling or abscess on the day of surgery
- Pregnancy
- Any condition or event that makes participation unsafe or not in the best interest of the participant
- Development of any medical condition during the study that might affect treatment or outcomes
- Starting any treatment or exposure that might affect healing during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo endodontic microsurgery (EMS) using a surgical microscope, followed immediately by either photobiomodulation (PBM) therapy or a sham treatment.
1 surgery visit (in-person)
Duration - 5 to 7 days after surgery
Participants have their sutures removed and healing assessed, with pain and wound healing evaluated up to 7 days after surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Juliana Barros, DDS,MS
K
Kala Morales
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here