Palatal Mucosa Wound Healing Following Antimicrobial Gel Application (BIOR_01)

University of Roma La Sapienza

Status: Active, not recruiting

Conditions: Wound Healing; Palate; Wound; Hyaluronic Acid

Treatments: Device: Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate; Device: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT06737653

0151/2023

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

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

Placebo group

Placebo Comparator group

Description:

Placebo gel

Treatment:

Device: Placebo gel