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Palatal Mucosa Wound Healing Following Antimicrobial Gel Application | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

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

NCT06737653•University of Roma La Sapienza

View on ClinicalTrials.gov

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

Age

18 - 38 years

Sex

ALL

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.

Locations (1)

Sapienza University of Rome

Rome, Rome, Italy

Key Dates

Start Date

December 22, 2024

Primary Completion Date

May 1, 2025

Completion Date

May 1, 2025

Last Updated

April 23, 2025

Enrollment

ESTIMATED participants

Conditions

Wound HealingPalate; WoundHyaluronic Acid

Interventions

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

DEVICE

Placebo gel

DEVICE

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

NCT07372404

Wound Healing

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RECRUITINGNA

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

NCT07330154

Wound HealingPalatal Wound+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

Inclusion Criteria

Exclusion Criteria

Allogeneic Adipose Tissue Extract in Wound Treatment and Scar Maturation

The Effectiveness of Nano Bio Fusion Gingival Gel (NBF) on Wound Healing at the Palate (Donor Site) After Soft Tissue Graft Surgery Compared to Placebo Gel.

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HIP-STITCH (Wound Recovery After THA)