Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

NCT06737653 | Active Not Recruiting

• 1 other identifier: 0151/2023
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

wound healing; palatal mucosa; hyaluronic acid; lactoferrin; postbiotics; aloe

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Healing Index (HI)

  HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30

• Secondary Healing Classification (SHC)

  SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30

• Complete epithelization (CE)

  CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.

• Oral Health Impact Profile-14 (OHIP-14)

  It will be evaluated at baseline and on post-operative days 1, 3, 7, 14, 21 and 30

• Functional Pain Scale (FPS)

  It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.

Study Arms (2)

antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

Placebo gel

Device: Placebo gel

Interventions

Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate DEVICE

The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.

antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium

Placebo gel DEVICE

The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.

Placebo group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Rome, 00161, Italy

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 17, 2024
• Study Start: December 22, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)