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ACTIVE NOT RECRUITING
NCT06737653
NA

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

Sponsor: University of Roma La Sapienza

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 38 Years

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2024-12-22

Completion Date

2025-05

Last Updated

2025-04-23

Healthy Volunteers

No

Interventions

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.

Locations (1)

Sapienza University of Rome

Rome, Rome, Italy