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 conventional postoperative care alone. 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
DEVICE940 nm GaAlAs diode laser
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
In the control group, only the palatal stent was applied without laser irradiation after suturing was completed at the recipient site
Sponsors
University of Medicine and Pharmacy at Ho Chi Minh City
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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 are 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 a palatal stent alone 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. |
| 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 of the palatal donor site | Day 7 and 14 after surgery | Epithelialization at the palatal donor site assessed as a binary outcome (yes/no) using a hydrogen peroxide bubbling test, classified as non-epithelialized (presence of bubbles) or completely epithelialized (absence of bubbles). |
| Remaining wound area | Immediately after surgery, 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 |
Countries
Vietnam
Outcome results
None listed