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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser group | Experimental | After suturing was completed at the recipient site, the donor site in the laser group was irradiated according to the manufacturer's recommended settings. Laser application was performed in the "Pain Therapy" mode using an Epic X diode laser (940 nm wavelength; 0.1 W power; energy density 4 J/cm²; continuous mode; exposure time 40 s; total energy 12 J). The laser beam was held perpendicular to the donor-site wound surface at 0.5 cm, with a spot size of 1 cm². Following irradiation, a palatal stent was placed. |
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| Control group | Active Comparator | After suturing was completed at the recipient site. In the control group, only the palatal stent was applied without laser irradiation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 940 nm GaAlAs diode laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Zero is equivalent to no pain and 10 indicates the worst possible pain. | 2 hours, 3 days, and 7 days after surgery |
| Post-surgical analgesic consumption | The number of 500-mg acetaminophen tablets consumed by participants during the first 3 days after surgery. | Within 3 days after surgery |
| Epithelialization of the palatal donor site | 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). | Day 7 and 14 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 | Immediately after surgery, and 3, 7, and 14 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City | Ho Chi Minh City | Vietnam |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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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
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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.
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| palatal stent | Device | In the control group, only the palatal stent was applied without laser irradiation after suturing was completed at the recipient site |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053685 |
| Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |