Use of a Custom-Made Acrylic Palatal Stent to Minimize Donor Site Morbidity After Suture-Free Epithelialized Gingival Graft Harvesting: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Healing; Mucogingival Defects
• Intervention / Treatment: Device: Custom-Made Acrylic Palatal Stent; Other: No Palatal stent

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino
    • Torino, Torino, Italy, 10126
      • C.I.R. Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custom-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.	Device: Custom-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.
Active Comparator: No 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	Other: No 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2025
• Primary Completion (Actual): March 24, 2026
• Study Completion (Actual): March 24, 2026

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: FGFTurin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No