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

University of Turin

Status: Completed

Conditions: Mucogingival Defects; Pain Management; Healing

Treatments: Other: No Palatal stent; Device: Custom-Made Acrylic Palatal Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT07501754

FGFTurin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

44 participants in 2 patient groups

Custom-Made Acrylic Palatal Stent

Experimental group

Description:

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.

Treatment:

Device: Custom-Made Acrylic Palatal Stent

No palatal stent

Active Comparator group

Description:

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

Treatment:

Other: No Palatal stent