Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronatePlacebo gel
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 gel: The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
38 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Color Match (CM) — CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30 CM will be evaluated comparing color of the adjacent and opposite sides again using VAS scores from 0 (no CM) to 10 (excellent CM)
Trial sites (1)
Facility
City
Region
Status
Sapienza University of Rome
Rome
Rome
More University of Roma La Sapienza trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
