Overview
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.
Eligibility
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)
