Healing, Mucogingival Defects, Pain Management
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICECustom-Made Acrylic Palatal Stent
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.
OTHERNo Palatal stent
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
Sponsors
University of Turin, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥18 years of age * Patients requiring periodontal plastic surgery involving epithelialized gingival graft (EGG) harvesting from the palate * Indications including keratinized tissue augmentation, soft tissue thickness augmentation, or root coverage procedures * Adequate palatal tissue thickness to allow graft harvesting (≥2 mm) * Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤20% * Ability to understand and complete patient-reported outcome questionnaires * Signed informed consent * Willingness to comply with study procedures and follow-up visits
Exclusion criteria
* compromised general health contraindicating the procedures (ASA III-VI) * heavy smokers (≥ 10 cigarettes/day), * systemic diseases or medications affecting treatment outcomes, * known allergies or hypersensitivity to ibuprofen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at the palatal donor site | 7 days after surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative bleeding | Daily from Day 1 to Day 7, Day 14, 21, 28 | Patient-reported bleeding at the palatal donor site assessed using a 100-mm VAS |
| Postoperative swelling | Daily from Day 1 to Day 7, day 14, 21, 28 | Patient-reported swelling assessed using a 100-mm VAS. |
| Analgesic consumption | 7 days after surgery | Total intake of ibuprofen (mg) recorded by patients during the postoperative period. |
| Oral health-related quality of life (OHIP-14) | Baseline, 7 days, 14 days, 21 days, 28 days | Oral health-related quality of life assessed using the OHIP-14 questionnaire |
| Willingness to undergo retreatment | 28 days after surgery | Patient willingness to undergo a similar procedure in the future (yes/no) |
| Epithelialization | 7 and 14 days after surgery | Wound epithelialization assessed using hydrogen peroxide (H₂O₂) test and classified as none, partial, or complete. |
| Clinical wound healing | 7, 14 days | Healing assessed from standardized photographs evaluating color match, tissue contour, and scar appearance using visual analog scales. |
Countries
Italy
Outcome results
None listed