Wound HealingBIOR_01NCT06737653
Palatal Mucosa Wound Healing Following Antimicrobial Gel Application
A study testing Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate in people with Wound Healing and Palate; Wound, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Wound Healing, Palate; Wound, Hyaluronic Acid
- What is being tested?
- Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 22 Dec 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Wound Healing, Palate; Wound, Hyaluronic Acid
- Being tested
- Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate, Placebo gel
- Keywords
- wound healing, palatal mucosa, hyaluronic acid, lactoferrin, postbiotics, aloe
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronateDevice
The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
Placebo gelDevice
The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
| Study group | Role | What they receive |
|---|---|---|
| antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium | Experimental | antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate Receives: Device: Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate |
| Placebo group | Placebo comparator | Placebo gel Receives: Device: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color Match (CM)
CM will be evaluated comparing color of the adjacent and opposite sides again using VAS scores from 0 (no CM) to 10 (excellent CM)
Measured: CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30
Secondary outcomes (8)
Healing Index (HI)
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.
Measured: HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Secondary Healing Classification (SHC)
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.
Measured: SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Complete epithelization (CE)
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."
Measured: CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Oral Health Impact Profile-14 (OHIP-14)
Participants will be also asked to complete the OHIP-14 questionnaire.
Measured: It will be evaluated at baseline and on post-operative days 1, 3, 7, 14, 21 and 30
Functional Pain Scale (FPS)
To assess pain experience and questions related to number of analgesics (NA) consumed and postoperative complications experienced during the first 14 days.
Measured: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Swelling
It will be also evaluated using VAS . VAS: from 0 (no swelling) to 10 (maximal swelling)
Measured: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Burning sensation
It will be also evaluated using VAS . VAS: from 0 (no burning sensation) to 10 (maximal burning sensation)
Measured: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Discomfort
It will be also evaluated using VAS . VAS: from 0 (no discomfort) to 10 (maximal discomfort)
Measured: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start22 Dec 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Split-mouth design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Pilloni MD DDS MS, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737653
- Sponsor's protocol ID
- 0151/2023
- Acronym
- BIOR_01
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06737653
- Acronym / sponsor ID
- BIOR_01 / 0151/2023
- Conditions
- Wound Healing, Palate; Wound, Hyaluronic Acid
- Keywords
- wound healing, palatal mucosa, hyaluronic acid, lactoferrin, postbiotics, aloe
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 22 Dec 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design
| Arm | Type | Receives |
|---|---|---|
| antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium | Experimental | Device: Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronateantimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate |
| Placebo group | Placebo comparator | Device: Placebo gelPlacebo gel |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- untreated periodontitis;
- previous surgery on the palate;
- history of poor wound healing;
- systemic diseases and/or coagulations disorders;
- pregnant or lactating;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronateThe gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min. | Device | antimicrobial gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium |
| Placebo gelThe gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min. | Device | Placebo group |
Primary outcome
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)
8 secondary outcomes
Healing Index (HI)
Time frame: HI will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Secondary Healing Classification (SHC)
Time frame: SHC will be assessed on post-operative days 1, 3, 7, 14, 21 and 30
Complete epithelization (CE)
Time frame: CE will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
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
Functional Pain Scale (FPS)
Time frame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Swelling
Time frame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Burning sensation
Time frame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Discomfort
Time frame: It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate in people with Wound Healing and Palate; Wound, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color Match (CM) (time frame: CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.