Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults
NCT07529340 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2026-04-20
Summary
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.
Conditions
- Gingival Recession, Mucogingival Surgery
Interventions
- PROCEDURE
-
Coronally Advanced Flap with Connective Tissue Graft
Standard periodontal plastic surgery procedure for root coverage involving coronally advanced flap (CAF) combined with a subepithelial connective tissue graft (SCTG). The technique aims to cover exposed root surfaces and improve soft tissue thickness and stability.
- DEVICE
-
Cross-linked Hyaluronic Acid Gel
Application of cross-linked hyaluronic acid gel (hyaDENT BG®) as an adjunct to periodontal surgery. The gel is applied to the recipient site and used to immerse the connective tissue graft prior to placement, aiming to enhance soft tissue healing, promote cell proliferation and angiogenesis, and improve clinical outcomes.
Sponsors & Collaborators
-
Regedent AG, Zürich
collaborator UNKNOWN -
Universidade do Porto
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- Portugal
Study Locations
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