Clinical trial NCT06737653: Palatal Mucosa Wound Healing Following Antimicrobial Gel Application
Official title: Effect of Antimicrobial Gel With Postbiotics, Lactoferrin, Aloe Barbadensis Leaf Juice Powder and Sodium Hyaluronate on Palatal Mucosa Wound Healing: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Wound Healing
Palate; Wound
Hyaluronic Acid
Keywords: wound healing
palatal mucosa
hyaluronic acid
lactoferrin
postbiotics
aloe
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Color Match (CM)
timeFrame: CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30
Secondary outcomes:
measure: Healing Index (HI)
timeFrame: HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
measure: Secondary Healing Classification (SHC)
timeFrame: SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
measure: Complete epithelization (CE)
timeFrame: CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
measure: Oral Health Impact Profile-14 (OHIP-14)
timeFrame: It will be evaluated at baseline and on post-operative days 1, 3, 7, 14, 21 and 30
measure: Functional Pain Scale (FPS)
timeFrame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
measure: Swelling
timeFrame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
measure: Burning sensation
timeFrame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
measure: Discomfort
timeFrame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
References: