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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Placebo group | Placebo Comparator | Placebo gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | CM will be evaluated on post-operative days 1, 3, 7, 14, 21 and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Rome | Rome | 00161 | Italy |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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Split-mouth design
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| Placebo gel | Device | The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min. |
|
| 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. | 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." | 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. | 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. | 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) | 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) | 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) | It will be assessed on post-operative days 1, 3, 7, 14, 21 and 30. |