Effect of GaAlAs 940 Laser on Pain and Wound Healing After Free Gingival Graft

• 940 nm GaAlAs diode laser (Device), also known as 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 stent (Device): 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.

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• Postoperative Pain (Primary), Mean, scores on a scale: Laser Group 1.08 +/- 0.28; Control Group 2.40 +/- 0.27
• Post-surgical Analgesic Consumption (Secondary), Median, tablets: Laser Group 1.5 (0.25 to 6.25); Control Group 5.0 (1.5 to 6.0)
• Epithelialization D7 (Secondary), Count of participants, Participants: Laser Group 0; Control Group 3
• Remaining Wound Area (Primary), Mean, mm²: Laser Group 152.28 +/- 15.70; Control Group 166.24 +/- 15.10
• Epithelialization D14 (Secondary), Count of participants, Participants: Laser Group 0; Control Group 1

Adverse events

Time frame: From the intervention through the 14-day postoperative follow-up.

• Study Protocol and Statistical Analysis Plan (PDF, 2024-10-01)