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Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in Adults

ConditionGingival Recession, Mucogingival Surgery
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Coronally Advanced Flap with Connective Tissue Graft

    Procedure/Surgery

    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.

  • Cross-linked Hyaluronic Acid Gel

    Device

    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.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: CAF + SCTG + Hyaluronic AcidExperimental treatment 2 interventions
Group B: CAF + SCTGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complete Root Coverage (CRC)

Proportion of treated sites achieving complete root coverage, defined as recession depth equal to 0 mm relative to the cemento-enamel junction, assessed using a calibrated periodontal probe by a blinded examiner.

Time frame
12 months

Secondary outcomes

1

Mean Root Coverage (MRC)

Percentage of root coverage achieved relative to baseline recession depth at the treated site.

Time frame
12 months
2

Recession Reduction (RecRed)

Change in gingival recession depth (mm) from baseline to follow-up, measured using a calibrated periodontal probe.

Time frame
12 months
3

Clinical Attachment Level (CAL) Gain

Change in clinical attachment level (mm) from baseline to 12 months, measured using a periodontal probe.

Time frame
12 months
4

Probing Depth (PD) Reduction

Reduction in probing depth (mm) from baseline to 12 months, measured using a periodontal probe.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidade do Porto

Lead sponsor

Regedent AG, Zürich

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: