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Epithelialized gingival graft (EGG) harvesting from the palate is associated with postoperative morbidity, including pain and bleeding, due to healing by secondary intention. The effectiveness of palatal stents in reducing donor-site morbidity, particularly in suture-free techniques, remains unclear.
This randomized controlled clinical trial evaluates the effect of a custom-made acrylic palatal stent (APS) compared with no stent on postoperative outcomes following EGG harvesting.
The primary outcome is postoperative pain assessed using a visual analog scale (VAS). Secondary outcomes include other patient-reported measures, clinician-reported healing, and exploratory assessments of tissue healing.
Epithelialized gingival graft (EGG) harvesting is widely used in periodontal plastic surgery but is associated with postoperative discomfort at the palatal donor site. Healing occurs by secondary intention and may result in pain, bleeding, and delayed recovery.
Palatal stents have been proposed as a mechanical approach to protect the wound and reduce morbidity; however, evidence supporting their effectiveness, especially in suture-free techniques, is limited.
This randomized controlled, assessor-blind, parallel-arm clinical trial aims to evaluate the effect of a custom-made acrylic palatal stent (APS) on postoperative morbidity following EGG harvesting. Patients were randomly assigned to receive APS or no stent after surgery.
The primary outcome is postoperative pain. Secondary outcomes include patient-reported measures, clinical healing parameters, and exploratory assessments of tissue healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-Made Acrylic Palatal Stent | Experimental | A custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention. Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol. |
|
| No palatal stent | Active Comparator | Following epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom-Made Acrylic Palatal Stent | Device | A custom-made acrylic palatal stent (APS) will be fabricated prior to surgery based on an impression of the maxillary arch. The device will be thermoformed, trimmed, polished, and adjusted for proper fit and retention. Following epithelialized gingival graft (EGG) harvesting, the APS will be positioned over the palatal donor site to provide mechanical protection and stabilization of the blood clot. The stent will be worn continuously during the early healing phase according to the study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain at the palatal donor site | Postoperative pain assessed using a 100-mm visual analog scale (VAS), where 0 indicates no pain and 100 indicates worst imaginable pain. Patients will record pain daily using standardized questionnaires | 7 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative bleeding | Patient-reported bleeding at the palatal donor site assessed using a 100-mm VAS | Daily from Day 1 to Day 7, Day 14, 21, 28 |
| Postoperative swelling | Patient-reported swelling assessed using a 100-mm VAS. |
| Measure | Description | Time Frame |
|---|---|---|
| Optical Coherence Tomography (OCT) parameters | Quantitative assessment of palatal tissue healing using OCT, including measurements of epithelial layer, keratin layer, and lamina propria thickness. | Baseline, 7, 14, 21, 28 days after surgery |
| Inflammatory biomarkers in wound exudate |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.I.R. Dental School | Torino | Torino | 10126 | Italy |
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|
| No Palatal stent | Other | Following epithelialized gingival graft (EGG) harvesting, no protective device will be applied to the palatal donor site. Hemostasis will be achieved through local anesthesia only, without the use of sutures, pressure, or additional hemostatic agents. Healing will occur by secondary intention |
|
| Daily from Day 1 to Day 7, day 14, 21, 28 |
| Analgesic consumption | Total intake of ibuprofen (mg) recorded by patients during the postoperative period. | 7 days after surgery |
| Oral health-related quality of life (OHIP-14) | Oral health-related quality of life assessed using the OHIP-14 questionnaire | Baseline, 7 days, 14 days, 21 days, 28 days |
| Willingness to undergo retreatment | Patient willingness to undergo a similar procedure in the future (yes/no) | 28 days after surgery |
| Epithelialization | Wound epithelialization assessed using hydrogen peroxide (H₂O₂) test and classified as none, partial, or complete. | 7 and 14 days after surgery |
| Clinical wound healing | Healing assessed from standardized photographs evaluating color match, tissue contour, and scar appearance using visual analog scales. | 7, 14 days |
Levels of inflammatory and healing-related biomarkers (e.g., IL-1β, IL-6, TGF-β1, VEGF-A) measured from palatal wound exudate using multiplex assay. |
| 4 days post surgery |
| Postoperative complications | Incidence of complications including infection, delayed healing, excessive bleeding, or other adverse events. | up to 28 days |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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