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Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

Study acronym: BIOR_01
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 23, 2025 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date: Mar 2025 to May 2025
    • Start date changed from estimate of Dec 2024 to Dec 22, 2024
    • Site contact updated
    v3
  2. Secondary endpoints: details revised at 2 of 8 entriesv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06737653
Lead Sponsor University of Roma La Sapienza
Conditions
(from sponsor)		 Wound Healing, Palate; Wound, Hyaluronic Acid
Related terms Wounds and Injuries
Enrollment 13 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov