MedTrace Logo

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

NCT06737653 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-04-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-22
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737653 on ClinicalTrials.gov