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Completed

NCT Number: NCT07501754

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.I.R. Dental School

Torino, 10126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Postoperative pain at the palatal donor site

    Time frame: 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 outcomes

  1. Postoperative bleeding

    Time frame: 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

  2. Postoperative swelling

    Time frame: Daily from Day 1 to Day 7, day 14, 21, 28

    Patient-reported swelling assessed using a 100-mm VAS.

  3. Analgesic consumption

    Time frame: 7 days after surgery

    Total intake of ibuprofen (mg) recorded by patients during the postoperative period.

  4. Oral health-related quality of life (OHIP-14)

    Time frame: Baseline, 7 days, 14 days, 21 days, 28 days

    Oral health-related quality of life assessed using the OHIP-14 questionnaire

  5. Willingness to undergo retreatment

    Time frame: 28 days after surgery

    Patient willingness to undergo a similar procedure in the future (yes/no)

  6. Epithelialization

    Time frame: 7 and 14 days after surgery

    Wound epithelialization assessed using hydrogen peroxide (H₂O₂) test and classified as none, partial, or complete.

  7. Clinical wound healing

    Time frame: 7, 14 days

    Healing assessed from standardized photographs evaluating color match, tissue contour, and scar appearance using visual analog scales.

Other outcomes

  1. Optical Coherence Tomography (OCT) parameters

    Time frame: Baseline, 7, 14, 21, 28 days after surgery

    Quantitative assessment of palatal tissue healing using OCT, including measurements of epithelial layer, keratin layer, and lamina propria thickness.

  2. Inflammatory biomarkers in wound exudate

    Time frame: 4 days post surgery

    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.

  3. Postoperative complications

    Time frame: up to 28 days

    Incidence of complications including infection, delayed healing, excessive bleeding, or other adverse events.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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