Hyaluronic Acid, Palate; Wound, Wound Healing
Conditions
Keywords
wound healing, palatal mucosa, hyaluronic acid, lactoferrin, postbiotics, aloe
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.
Interventions
DEVICEGel containing postbiotics, lactoferrin, aloe barbadensis leaf juice powder and sodium hyaluronate
The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
DEVICEPlacebo gel
The gel will be applied until the wound is filled with the gel, which will be left undisturbed for 5 min.
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Split-mouth design
Eligibility
Sex/Gender
ALL
Age
18 Years to 38 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Color Match (CM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Healing Classification (SHC) | 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. |
| Complete epithelization (CE) | 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. |
| Oral Health Impact Profile-14 (OHIP-14) | 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. |
| Healing Index (HI) | 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. |
| Swelling | 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) |
| Burning sensation | 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) |
| Discomfort | 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) |
| Functional Pain Scale (FPS) | 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. |
Countries
Italy
Outcome results
None listed