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NCT Number: NCT06737653

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Wound Healing Hyaluronic Acid Palate; Wound Wounds and Injuries

Age range

18 year–38 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Rome, 00161, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo gel

Device

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

Primary outcomes

  1. Color Match (CM)

    Time frame: 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)

Secondary outcomes

  1. Healing Index (HI)

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

    The Pippi modification of the Landry index will be calculated as the sum of seven parameters, each of them will be observed clinically and then will receive a dichotomic score (0/1): a total score of 7 will be associated with better healing process. The assessed parameters will be the following:

    • Presence or absence of redness;
    • Presence or absence of granulation tissue;
    • Presence or absence of suppuration;
    • Presence or absence of swelling;
    • Degree of tissue re-epithelization (partial or complete);
    • Presence or absence of bleeding;
    • Presence or absence of pain on palpation.

  2. Secondary Healing Classification (SHC)

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

    This Classification is composed by 3 classes (I,II,III) and 3 sub-classes (a,b,c). Class I and Sub-class a are associated with complete wound closure and optimal healing.

  3. Complete epithelization (CE)

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

    CE will be assessed clinically after direct visualization via inspection supported by means of clinical photographs taken at each post-surgical visit to provide insight into the differences among patients across all groups. CE will recorded as dichotomous scoring by a clinical investigator masked to all groups as "yes" or "no" according to inspectional evaluation of surface characteristics and reflection as well as clarity and distinctness of wound outline. If the epithelial barrier is intact and if distinction of a demarcation line is unclear when assessing the edges, CE was scored as "yes."

  4. Oral Health Impact Profile-14 (OHIP-14)

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

    Participants will be also asked to complete the OHIP-14 questionnaire.

  5. Functional Pain Scale (FPS)

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

    To assess pain experience and questions related to number of analgesics (NA) consumed and postoperative complications experienced during the first 14 days.

  6. Swelling

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

    It will be also evaluated using VAS . VAS: from 0 (no swelling) to 10 (maximal swelling)

  7. Burning sensation

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

    It will be also evaluated using VAS . VAS: from 0 (no burning sensation) to 10 (maximal burning sensation)

  8. Discomfort

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

    It will be also evaluated using VAS . VAS: from 0 (no discomfort) to 10 (maximal discomfort)

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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

Acronym: BIOR_01

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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