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Completed
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
Conditions: Pain Management, Mucogingival Defects, Healing
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 44
Sponsor: University of Turin, Italy
Location: C.I.R. Dental School Torino Torino
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07501754). StuddyBuddy aggregates publicly available trial information.