Palatal Wound
Conditions
Keywords
Topical hyaluronic acid, Postoperative pain, Wound healing, Epithelialized, Palate, supportive care, Treatment, Prevention
Brief summary
This clinical study aims to investigate the impact of a topical hyaluronic acid (HA) gel on postoperative pain and wound healing at palatal donor sites in patients undergoing mucogingival procedures involving a de-epithelialized gingival graft (DGG) from the palate. The study design is a Phase III, randomized, double-blind, parallel-group, clinical trial, conducted in a single center, with 30 subjects aged 18-70 years.
Interventions
DEVICEHyaluronic acid
Hyaluronic acid and hemostatic sponge
DEVICEControl
Hemostatic sponge
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females, between 18-70 years of age * Informed Consent Form signed and availability for the duration of the study * Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study * Clinical indication for mucogingival surgery that requires a de-epithelialized gingival graft (DGG) from the palate * Willingness to provide information related to their medical history * Minimum of 10 uncrowned permanent natural teeth (excluding third molars) * Normal salivary flow
Exclusion criteria
* Oral pathology, chronic disease, or a history of allergy to testing products * Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study * Subject participating in any other clinical study * Subject pregnant or breastfeeding * Subject allergic to oral care products, personal care consumer products, or their ingredients * Extended use of antibiotics or therapeutic mouthwash any time during the three months prior to entry into the study * A medical history reporting that the subject has a current systemic or autoimmune disease, such as diabetes, lupus, etc * Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing area | Baseline | Wound size will be assessed at Baseline after obtaining the graft, and 3, 7, 14, 21, and 42 days after surgery via direct measurement with a Periodontal Probe UNC 15 (Hu-Friedy, United States), length and height of the wound will be measured and recorded to the nearest millimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment | Baseline | Pain will be assessed via Visual Analog Scale (VAS) at Baseline, 3, 7, 14, 21, and 42 days after surgery. A line of 10 cm will be used in which at the left end of the line will have a verbal anchor stating No pain and on the other end the verbal anchor of The most intense pain that I ever felt. The subjects will place a mark on the line and the distance from the beginning of the line up to the mark will be measured and recorded. |
Countries
Brazil
Outcome results
None listed