NCT06737653

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

Effect of Antimicrobial Gel With Postbiotics, Lactoferrin, Aloe Barbadensis Leaf Juice Powder and Sodium Hyaluronate on Palatal Mucosa Wound Healing: a Randomized Clinical Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

The present study will be a prospective, randomized, triple-blind, split-mouth, clinical trial. The study timeline will be include seven total visits. After a screening/study enrolment visit, a wounding surgery visit (Day 0) will be schedule. On Day 0, one standardized wound will be created on each side of the palate (DFGG required for root coverage procedure). Each side of the palate randomly received either antimicrobial gel (treatment group) or placebo (control group) at day 0, 1 and 3. The patients, an experienced periodontist who performed the surgical procedures and the clinical examiners will be blinded to treatment allocation. Clinical healing response and patient related outcome measures (PROMs) will be evaluated on postoperative Day 1, 3, 7, 14, 21 and 30.

Conditions

• Wound Healing
• Palate; Wound
• Hyaluronic Acid

Interventions

Type	Name	Description
DEVICE	Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate	The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
DEVICE	Placebo gel	The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.

Timeline

• Start date: 2024-12-22
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-12-17
• Last updated: 2025-04-23

Locations

1 site across 1 country: Italy