Palatal Mucosa Wound Healing Following Antimicrobial Gel Application (BIOR_01)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Wound Healing; Palate; Wound; Hyaluronic Acid
• Intervention / Treatment: Device: Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate; Device: Placebo gel

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00161
    • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged 18 to 38 years (age limits based on evidence of delayed wound healing in older adults, Engeland et al., 2006);
• full-mouth plaque score and full-mouth bleeding score ≤ 15% at study entry;
• adequate anteroposterior arch length for required wound size and spacing;
• able to easily tolerate maxillary impression making and use of palatal template;
• patients required at least two root coverages procedures in one tooth in different sextants with DFGG;
• palate with no pathological or morphological alteration.

Exclusion Criteria:

• untreated periodontitis;
• previous surgery on the palate;
• history of poor wound healing;
• systemic diseases and/or coagulations disorders;
• pregnant or lactating;
• smoking or marijuana use (non-smoker status verified by exhaled air carbon monoxide as previously described);
• medications affecting periodontal status (e.g. phenytoin, calcium channel blockers and cyclosporine);
• therapy with anticoagulants, nonsteroidal anti-inflammatory drugs, corticosteroids, or any drug interfering with the healing process during the previous six months;
• contraindication to receiving any of the active components of the antimicrobial gel.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium; antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate	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.
Placebo Comparator: Placebo group; Placebo gel	Device: Placebo gel; The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Healing Classification (SHC)	This Classification is composed by 3 classes (I,II,III) and 3 sub-classes (a,b,c). Class I and Sub-class a are associated with complete wound closure and optimal healing.	SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Complete epithelization (CE)	CE will be assessed clinically after direct visualization via inspection supported by means of clinical photographs taken at each post-surgical visit to provide insight into the differences among patients across all groups. CE will recorded as dichotomous scoring by a clinical investigator masked to all groups as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. If the epithelial barrier is intact and if distinction of a demarcation line is unclear when assessing the edges, CE was scored as "yes."	CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Oral Health Impact Profile-14 (OHIP-14)	Participants will be also asked to complete the OHIP-14 questionnaire.	It will be evaluated at baseline and on post-operative days 1, 3, 7, 14, 21 and 30
Swelling	It will be also evaluated using VAS . VAS: from 0 (no swelling) to 10 (maximal swelling)	It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Burning sensation	It will be also evaluated using VAS . VAS: from 0 (no burning sensation) to 10 (maximal burning sensation)	It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Discomfort	It will be also evaluated using VAS . VAS: from 0 (no discomfort) to 10 (maximal discomfort)	It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Healing Index (HI)	The Pippi modification of the Landry index will be calculated as the sum of seven parameters, each of them will be observed clinically and then will receive a dichotomic score (0/1): a total score of 7 will be associated with better healing process. The assessed parameters will be the following: Presence or absence of redness;; Presence or absence of granulation tissue;; Presence or absence of suppuration;; Presence or absence of swelling;; Degree of tissue re-epithelization (partial or complete);; Presence or absence of bleeding;; Presence or absence of pain on palpation.	HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Functional Pain Scale (FPS)	To assess pain experience and questions related to number of analgesics (NA) consumed and postoperative complications experienced during the first 14 days.	It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 11, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: wound healing; lactoferrin; hyaluronic acid; aloe; postbiotics; palatal mucosa
• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents; Immunologic Factors; Physiological Effects of Drugs; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid; Lactoferrin
• Other Study ID Numbers: 0151/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No