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

NCT07501754 | Completed

• 1 other identifier: FGFTurin
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Mucogingival Defects; Healing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Postoperative bleeding

  Daily from Day 1 to Day 7, Day 14, 21, 28

• Postoperative swelling

  Daily from Day 1 to Day 7, day 14, 21, 28

• Analgesic consumption

  7 days after surgery

• Oral health-related quality of life (OHIP-14)

  Baseline, 7 days, 14 days, 21 days, 28 days

• Willingness to undergo retreatment

  28 days after surgery

Other Outcomes (3)

• Optical Coherence Tomography (OCT) parameters

  Baseline, 7, 14, 21, 28 days after surgery

• Inflammatory biomarkers in wound exudate

  4 days post surgery

• Postoperative complications

  up to 28 days

Study Arms (2)

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.

Device: Custom-Made Acrylic Palatal Stent

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

Other: No Palatal stent

Interventions

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.

Custom-Made Acrylic Palatal Stent

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

No palatal stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

C.I.R. Dental School

Torino, Torino, 10126, Italy

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mario Aimetti

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: January 7, 2025
• Primary Completion: March 24, 2026
• Study Completion: May 24, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

IT (1)