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Gingival Recession, Mucogingival SurgeryNCT07529340

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

A study testing Coronally Advanced Flap with Connective Tissue Graft and Cross-linked Hyaluronic Acid Gel in people with Gingival Recession, Mucogingival Surgery, run by Universidade do Porto at 1 site in Portugal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gingival Recession, Mucogingival Surgery
What is being tested?
Coronally Advanced Flap with Connective Tissue Graft and Cross-linked Hyaluronic Acid Gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 sitePortugal
Study dates
May 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • - 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%)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marta M Abreu-Costa contact

+351911834256

martacostaa11@gmail.com

Portugal1 site
  • CEPI - Clinical Center for Periodontology and Implantology

    Porto, Porto District, 4350-110

    Marta M Abreu-Costa, +351911834256, martacostaa11@gmail.com

Other trials in Portugal

About this study

Official title: Effectiveness of Hyaluronic Acid Application in Coronally Advanced Flap Combined With a Subepithelial Connective Tissue Graft Versus Coronally Advanced Flap Combined With a Subepithelial Connective Tissue Graft Alone: A Clinical 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.

Read more

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.

Read the detailed description

Gingival recession (GR) is a common mucogingival condition characterized by apical displacement of the gingival margin beyond the cemento-enamel junction, leading to root exposure, dentin hypersensitivity, increased risk of root caries, and aesthetic impairment. The coronally advanced flap combined with a subepithelial connective tissue graft (CAF + SCTG) is considered the gold standard for the treatment of single gingival recession defects, providing predictable root coverage and long-term stability. However, postoperative morbidity, donor-site discomfort, and incomplete root coverage may still occur.

Hyaluronic acid (HA) is a key component of the extracellular matrix with biological properties that promote wound healing, including stimulation of angiogenesis, cell migration, proliferation, and modulation of inflammatory responses. Cross-linked HA formulations exhibit prolonged bioactivity and may enhance soft tissue healing and regeneration in periodontal surgery.

This study is a prospective, randomized, controlled, post-market clinical follow-up (PMCF) trial designed to evaluate the clinical effectiveness and safety of adjunctive cross-linked hyaluronic acid (hyaDENT BG®) in combination with CAF + SCTG for the treatment of single RT1 and RT2 gingival recession defects. A total of 34 patients will be enrolled and randomly allocated in a 1:1 ratio to either the test group (CAF + SCTG with adjunctive HA) or the control group (CAF + SCTG alone). Randomization will be stratified by recession type (RT1 vs RT2), and outcome assessors will be blinded to treatment allocation.

The primary endpoint is complete root coverage (CRC) at 12 months, defined as recession depth equal to 0 mm relative to the cemento-enamel junction. Secondary endpoints include mean root coverage, recession reduction, clinical attachment level gain, probing depth reduction, keratinized tissue gain, early wound healing (Early Wound Healing Score), patient-reported outcomes (pain, discomfort, and oral health-related quality of life), and aesthetic outcomes assessed using the Root Coverage Esthetic Score (RES).

Clinical assessments will be performed at baseline and at predefined follow-up visits up to 12 months post-surgery using standardized protocols and calibrated examiners. Patient-reported outcomes will be collected using validated instruments, including visual analog scales (VAS) and the OHIP-14 questionnaire.

In parallel, an in vitro component will be conducted using primary human gingival fibroblasts isolated from connective tissue grafts obtained during surgery. These cells will be used to evaluate the effects of HA on cell viability, proliferation, migration, gene expression related to wound healing and inflammation, and activation of intracellular signaling pathways.

This combined clinical and translational approach aims to provide comprehensive evidence on both the clinical performance and biological mechanisms of action of hyaluronic acid in periodontal plastic surgery.

Being tested
Coronally Advanced Flap with Connective Tissue Graft, Cross-linked Hyaluronic Acid Gel
Keywords
Gingival recession, Coronally advanced flap, Connective tissue graft, Hyaluronic acid, Mucogingival surgery
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronally Advanced Flap with Connective Tissue GraftProcedure or surgery

    Also called CAF + SCTG

    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 GelDevice

    Also called hyaDENT BG®

    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.

Study groups in NCT07529340
Study groupRoleWhat they receive
CAF + SCTG + Hyaluronic AcidExperimentalParticipants undergo coronally advanced flap (CAF) surgery combined with a subepithelial connective tissue graft (SCTG) with adjunctive application of cross-linked hyaluronic acid (hyaDENT BG®). The graft is immersed in hyaluronic acid prior to placement, and the gel is applied to the recipient site before flap closure.
Receives: Procedure: Coronally Advanced Flap with Connective Tissue Graft; Device: Cross-linked Hyaluronic Acid Gel
CAF + SCTGActive comparatorParticipants undergo coronally advanced flap (CAF) surgery combined with a subepithelial connective tissue graft (SCTG) without adjunctive hyaluronic acid. The graft is handled under standard conditions and hydrated with sterile saline prior to placement.
Receives: Procedure: Coronally Advanced Flap with Connective Tissue Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)
  1. Mean Root Coverage (MRC)

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

    Measured: 12 months

  2. Recession Reduction (RecRed)

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

    Measured: 12 months

  3. Clinical Attachment Level (CAL) Gain

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

    Measured: 12 months

  4. Probing Depth (PD) Reduction

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

    Measured: 12 months

  5. Keratinized Tissue Width (KT) Gain

    Increase in the width of keratinized gingiva (mm) from baseline to follow-up.

    Measured: 12 months

  6. Early Wound Healing Score (EHS)

    Assessment of early soft tissue healing using the Early Wound Healing Score at predefined postoperative time points.

    Measured: 3 days, 14 days, and 6 weeks

  7. Postoperative Pain and Discomfort (VAS)

    Patient-reported pain and discomfort assessed using a visual analog scale (VAS).

    Measured: 3 days, 14 days, and 6 weeks

  8. Oral Health-Related Quality of Life (OHIP-14)

    Patient-reported oral health-related quality of life measured using the OHIP-14 questionnaire.

    Measured: 3 days, 14 days, and 6 weeks

  9. Root Coverage Esthetic Score (RES)

    Esthetic outcome assessed using the Root Coverage Esthetic Score based on standardized clinical photographs.

    Measured: 12 months

  10. Surgical and Postoperative Complications

    Incidence of intraoperative and postoperative complications, including flap dehiscence, infection, or graft necrosis.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07529340
Sponsor's protocol ID
24/2023
Status last verified
Mar 2026
First submitted
7 Apr 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: No final decision has been made regarding individual participant data sharing. Data sharing will be considered in accordance with applicable regulations and institutional policies.

Publications

  • Guldener K, Lanzrein C, Eliezer M, Katsaros C, Stahli A, Sculean A. Treatment of single mandibular recessions with the modified coronally advanced tunnel or laterally closed tunnel, hyaluronic acid, and subepithelial connective tissue graft: a report of 12 cases. Quintessence Int. 2020;51(6):456-463. doi: 10.3290/j.qi.a44492.

    PubMed 32368762
  • Asparuhova MB, Kiryak D, Eliezer M, Mihov D, Sculean A. Activity of two hyaluronan preparations on primary human oral fibroblasts. J Periodontal Res. 2019 Feb;54(1):33-45. doi: 10.1111/jre.12602. Epub 2018 Sep 27.

    PubMed 30264516
  • Pilloni A, Schmidlin PR, Sahrmann P, Sculean A, Rojas MA. Effectiveness of adjunctive hyaluronic acid application in coronally advanced flap in Miller class I single gingival recession sites: a randomized controlled clinical trial. Clin Oral Investig. 2019 Mar;23(3):1133-1141. doi: 10.1007/s00784-018-2537-4. Epub 2018 Jun 30.

    PubMed 29961138

Questions about this trial

What is this clinical trial studying?

A study testing Coronally Advanced Flap with Connective Tissue Graft and Cross-linked Hyaluronic Acid Gel in people with Gingival Recession, Mucogingival Surgery, run by Universidade do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta M Abreu-Costa (+351911834256, martacostaa11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Root Coverage (CRC) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07529340, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

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