Effect of Antimicrobial Gel With Postbiotics, Lactoferrin, Aloe Barbadensis Leaf Juice Powder and Sodium Hyaluronate on Palatal Mucosa Wound Healing: a Randomized Clinical Trial (BIOR_01)

NCT06737653 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	University of Roma La Sapienza
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	13
Start date	2024-12-22
Completion	2025-05

Conditions

• Wound Healing
• Palate; Wound
• Hyaluronic Acid

Interventions

• Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate
• Placebo gel

Primary outcomes

• Color Match (CM) — CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30
  CM will be evaluated comparing color of the adjacent and opposite sides again using VAS scores from 0 (no CM) to 10 (excellent CM)

Countries

Italy