Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults (NCT07529340) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults
Portugal34 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 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
* No active periodontal disease (probing depth ≤ 4 mm and no bleeding on probing at the selected tooth)
* Full-Mouth Plaque Score (FMPS ≤ 20%) and Full-Mouth Bleeding Score (FMBS ≤ 20%)
* Vital tooth without caries, cervical lesions, or defective restorations
* Good oral hygiene and motivation to maintain plaque control
* Ability and willingness to comply with study procedures
* Signed informed consent
Exclusion Criteria:
* 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
* Heavy smokers (\>10 cigarettes/day) or recent tobacco use
* Active periodontal disease at the study site
* Caries, root fractures, endodontic lesions, or defective restorations at the study tooth
* Previous mucogingival surgery at the study site
* Recent use of antibiotics, corticosteroids, or anti-inflammatory drugs
* Coagulation disorders or anticoagulant therapy contraindicating surgery
* Hormonal disorders affecting wound healing
* Acute oral infections
* Any condition that may interfere with study participation or follow-up
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.