Low Level Laser TherapyNCT07308912
Effect of GaAlAs 940 Laser on Pain and Wound Healing After Free Gingival Graft
A study testing 940 nm GaAlAs diode laser and palatal stent in people with Low Level Laser Therapy and Healthy, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Level Laser Therapy, Healthy, Postoperative Pain Management
- What is being tested?
- 940 nm GaAlAs diode laser and palatal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age;
- systemically healthy individuals without any conditions that could affect wound healing (e.g., diabetes, immunosuppression, coagulation disorders, Candida infection;
- full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) <15%;
- no previous history of palatal tissue harvesting;
- no use of overdentures or partial dentures covering the donor area.
Who cannot join
- pregnant or breastfeeding women;
- smokers;
- patients with psychiatric disorders; and
- patients taking any medications that impair tissue healing and affect pain perception.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: Single Application 940 nm GaAlAs Photobiomodulation Immediately After Free Gingival Graft Harvesting: Randomized Controlled Trial of Early Postoperative Pain and Palatal Wound Area Reduction
This randomized controlled clinical trial aims to evaluate the biomodulatory effects of a 940-nm GaAlAs diode laser on postoperative pain control and wound healing at the palatal donor site following free gingival graft harvesting. Adult patients undergoing free gingival graft surgery will be randomly allocated to receive either a single session of adjunctive diode laser irradiation immediately after surgery or sham laser irradiation without therapeutic laser energy delivery. Postoperative pain will be assessed using a visual analog scale, while clinical parameters related to wound healing, including bleeding tendency, epithelialization, and wound size reduction, will be evaluated at predefined follow-up time points. The findings of this study may contribute to the clinical understanding of photobiomodulation in free gingival graft surgery.
- Being tested
- 940 nm GaAlAs diode laser, palatal stent
- Keywords
- low level laser therapy, palatal donor site, free gingival harvesting, pain control, palatal wound healing, photobiomodulation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
940 nm GaAlAs diode laserDevice
Also called Diode laser, Low-level laser therapy (LLLT), Photobiomodulation therapy (PBMT)
A single session of 940-nm GaAlAs diode laser irradiation is applied to the palatal donor site immediately after free gingival graft harvesting using a continuous, non-contact mode (0.1 W, 4 J/cm² for 40 seconds), in combination with the use of a palatal stent.
palatal stentDevice
After suturing was completed at the recipient site, sham laser irradiation was performed without therapeutic laser energy delivery, followed by placement of a palatal stent.
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Experimental | After suturing was completed at the recipient site, the palatal donor site in the laser group was irradiated according to the manufacturer's recommended settings using an Epic X diode laser (940-nm wavelength; 0.1-W power; energy density, 4 J/cm²; continuous-wave mode; exposure time, 40 s per field; total energy, 12 J). The laser beam was positioned perpendicular to the wound surface at a distance of 0.5 cm, with a spot size of 1 cm². Following irradiation, a palatal stent was placed. Receives: Device: 940 nm GaAlAs diode laser; Device: palatal stent |
| Control group | Sham comparator | After suturing was completed at the recipient site, sham laser irradiation was performed using the same procedure as in the laser group but without therapeutic laser energy delivery. A palatal stent was subsequently placed. Receives: Device: palatal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: 2 hours, 3 days, and 7 days after surgery
Remaining Wound Area
Changes in palatal donor site wound area measured using serial intraoral digital scans obtained at predefined follow-up time points
Measured: Immediately after surgery prior to laser irradiation (baseline on day 0), and 3, 7, and 14 days after surgery
Secondary outcomes (3)
Post-surgical Analgesic Consumption
The number of 500-mg acetaminophen tablets consumed by participants during the first 3 days after surgery.
Measured: Within 3 days after surgery
Epithelialization D7
Epithelialization was assessed by applying 3% hydrogen peroxide (H₂O₂) to the palatal donor site. Bubbling indicated areas without epithelial coverage. Epithelialization was classified as no epithelialization when bubbling was observed over the entire wound area, partial epithelialization when bubbling was observed over only part of the wound area, and complete epithelialization when no bubbling was observed over the wound area.
Measured: Day 7
Epithelialization D14
Epithelialization was assessed by applying 3% hydrogen peroxide (H₂O₂) to the palatal donor site. Bubbling indicated areas without epithelial coverage. Epithelialization was classified as no epithelialization when bubbling was observed over the entire wound area, partial epithelialization when bubbling was observed over only part of the wound area, and complete epithelialization when no bubbling was observed over the wound area.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Level Laser TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to two groups: a laser group receiving adjunctive 940-nm diode laser irradiation in combination with a palatal stent, and a control group receiving sham laser irradiation without therapeutic laser energy delivery in combination with a palatal stent following free gingival graft harvesting.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Thanh Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308912
- Sponsor's protocol ID
- 1976/ĐHYD-HĐĐĐ
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2025
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes