Low Level Laser Therapy, Healthy, Postoperative Pain Management, Wound Healing
Conditions
Keywords
low level laser therapy, palatal donor site, free gingival harvesting, pain control, palatal wound healing, photobiomodulation
Brief 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. 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.
Interventions
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.
DEVICEpalatal stent
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.
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Periodontal surgeries are performed by a periodontist with more than 20 years of clinical experience, who is not involved in laser irradiation or clinical outcome assessment. Laser irradiation and digital scanning of the palatal wound area are performed by a trained investigator who does not participate in clinical outcome evaluation. Clinical assessments and measurements of scanned images are conducted by an independent periodontist who is blinded to group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥18 years of age; 2. systemically healthy individuals without any conditions that could affect wound healing (e.g., diabetes, immunosuppression, coagulation disorders, Candida infection; 3. full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) \<15%; 4. no previous history of palatal tissue harvesting; 5. no use of overdentures or partial dentures covering the donor area.
Exclusion criteria
1. pregnant or breastfeeding women; 2. smokers; 3. patients with psychiatric disorders; and 4. patients taking any medications that impair tissue healing and affect pain perception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 2 hours, 3 days, and 7 days after surgery | Zero is equivalent to no pain and 10 indicates the worst possible pain. |
| Remaining Wound Area | Immediately after surgery prior to laser irradiation (baseline on day 0), and 3, 7, and 14 days after surgery | Changes in palatal donor site wound area measured using serial intraoral digital scans obtained at predefined follow-up time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-surgical Analgesic Consumption | Within 3 days after surgery | The number of 500-mg acetaminophen tablets consumed by participants during the first 3 days after surgery. |
| Epithelialization D7 | Day 7 | 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. |
| Epithelialization D14 | Day 14 | 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. |
Countries
Vietnam
Participant flow
Recruitment details
Participants were recruited from patients requiring autogenous palatal soft-tissue graft harvesting at the Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City, Vietnam, between October 2024 and October 2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34 Years |
| Palatal donor site wound area | 166.24 mm² STANDARD_DEVIATION 55.94 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment Vietnam | 17 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 16 |
| other Total, other adverse events | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
None listed