Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade do Porto
About this trial
Gingival recession is a common condition in which the gum tissue recedes, exposing the root surface of the tooth. This can lead to tooth sensitivity, higher risk of root decay, and aesthetic concerns. A commonly used surgical treatment is the coronally advanced flap combined with a connective tissue graft (CAF + SCTG), which aims to cover the exposed root and improve gum health.
Hyaluronic acid (HA) is a naturally occurring substance in the body that plays an important role in wound healing. It may help improve tissue repair, reduce inflammation, and enhance healing after surgery.
This study aims to evaluate whether the use of hyaluronic acid (hyaDENT BG®) in addition to standard surgical treatment improves clinical outcomes in patients with gingival recession. Participants will be randomly assigned to receive either standard treatment alone or standard treatment with hyaluronic acid.
The main outcome is the proportion of sites with complete root coverage after 12 months. Additional outcomes include healing, gum tissue improvement, patient-reported pain and discomfort, and aesthetic results.
The study also includes a laboratory component to investigate how hyaluronic acid affects cells involved in gum healing.
Eligibility criteria
Qualifiers
- Age ≥ 18 years, in good general health (ASA I or II)
Presence of a single gingival recession defect classified as RT1 or RT2
Recession depth ≥ 2 mm with identifiable cemento-enamel junction (CEJ)
Presence of at least 1 mm of keratinized tissue at the defect site
Disqualifiers
Uncontrolled systemic diseases (e.g., uncontrolled diabetes, severe cardiovascular disease, immunodeficiency)
Pregnant or breastfeeding women
Autoimmune diseases or immunosuppressive therapy
Known hypersensitivity to hyaluronic acid
Trial design
Treatments tested in this trial
- Coronally Advanced Flap with Connective Tissue Graft
- Cross-linked Hyaluronic Acid Gel
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universidade do Porto
Lead sponsor
Regedent AG, Zürich
Collaborator
Source ClinicalTrials.gov