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Gingival RecessionNCT06330662

Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap

A study of Gingival Recession, run by Andelina Sekelja at 1 site in Croatia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gingival Recession
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteCroatia
Study dates
1 Sep 2023to 1 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age ≥ 18 years
  • people without systemic diseases and chronic regular therapy
  • non-smokers
  • percentage of areas affected by plaque (FMPS) and percentage of bleeding sites on probing (FMBS) ≤25%
  • the presence of a non-carious cervical lesion (NCCL) associated with recession
  • gingival recessions on at least two adjacent teeth with a minimum depth of 2 mm and a clearly visible enamel-cement junction
  • selection of patients capable of understanding and maintaining oral hygiene instructions with regular follow-up appointments
  • selection of patients who fully understand the nature of the proposed surgical procedure and agree to informed consent

Who cannot join

  • untreated periodontitis
  • the presence of fixed prosthetic work (crown or bridge) on the examined adjacent teeth
  • smokers
  • pregnant and lactating women
  • patients with uncontrolled type I and II diabetes
  • patients with medical contraindications for surgical therapy
Show all 13Show fewer
  • medical history related to malignancies, radiotherapy, chemotherapy for the last 5 years
  • taking chronic therapy that affects soft tissue healing such as: steroids, high doses of anti-inflammatory drugs, anticoagulants
  • patients with active systemic infection
  • allergies to hyaluronic acid
  • allergies to local anesthesia
  • alcohol or drug use
  • participation in another clinical research in the past 6 months

Trial locations and contacts

1 site in 1 country.

Croatia1 site
  • University of Zagreb - School of dental medicine

    Zagreb, Hrvatska, 10 000

Other trials in Croatia

About this study

Official title: Effectiveness of Hyaluronic Acid on Multiple Adjacent Gingival Recessions Using a Coronally Advanced Flap: Randomized Controlled Trial With One Year Follow-up

The goal of this clinical randomized trial is to examine the effectiveness of hyaluronic acid in treatment of multiple adjacent gingival recessions in 2 groups. Control group will be presented by using a coronally advanced flap only (CAF) and experimental group will be presented with addition of hyaluronic acid to a coronally advanced flap (CAF+HA). The main question it aims to answer is: is there any difference in the reduction of multiple gingival recessions between the control (CAF) and the test group (CAF + HA)? The research would be conducted on subjects referred for specialist treatment at the Department of Periodontology (Faculty of dental medicine, University of Zagreb). A record would be kept of all patients who underwent a detailed clinical examination, those who did not meet the criteria for inclusion in the study and those who refused to participate in it. Participants who meet the inclusion criteria will undergo a detailed clinical examination and if they agree to participate in the research, they will sign the informed form. During the pre-treatment, patients will receive instructions and a demonstration on proper maintenance of oral hygiene as well as a teeth cleaning. In addition to the informed form, they will fill out the OHIP-14 questionnaire, and the researcher will measure the periodontal indices at the very beginning before the operation, as well as the Schiff index. Patients will be photographed at the baseline as well as at follow-up examinations. The total number of subjects would be 42, or 21 patients in the 2 observed groups. The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA).

Read the detailed description

Gingival recession is defined as a shift of the gingival margin towards the apical side in relation to the cemento-enamel junction, and teeth with a thinner periodontal phenotype are considered more prone to the same occurrence (Jepsen et al., 2018). The coronally advanced flap surgical technique is used to cover root recessions of one or more teeth, if sufficient tissue is present to be mobilized. In 2000., Zucchelli and de Sanctis described the coronally advanced flap technique for covering multiple adjacent gingival recessions in one procedure, and it is applicable and used in clinical practice.

Hyaluronic acid (HA) is a biocompatible and non-immunogenic linear polysaccharide of high molecular mass present in periodontal tissue that has anti-inflammatory and bacteriostatic effects and promotes healing of the surrounding tissue. The potential benefit of adding hyaluronic acid (HA) to the coronally advanced flap (CAF) operative technique to cover multiple adjacent recessions has not been sufficiently investigated. Improving esthetics is one of the primary goals of root recession coverage surgery procedures, and little is known about the same in multiple adjacent gingival recession coverage therapy. In patients with a sufficient amount (≥2 mm) of keratinized tissue, the coronally advanced flap (CAF) has been shown to be very effective in the treatment of multiple recessions, especially in terms of aesthetic results (Chambrone et al., 2018; Pini-Prato et al., 2014.) . The authors concluded by searching databases (Epistemonikos, Cochrane, Medline) that there is no evidence supporting the use of HA + CAF to achieve greater root coverage in the treatment of multiple adjacent gingival recessions.

The aim of this study is to examine the clinical efficacy of HA in combination with CAF for the treatment of multiple gingival recessions in root coverage, width and thickness of keratinized gingiva, and patient-reported clinical outcomes compared to CAF alone as monotherapy.

Implications: It is important for clinicians to choose an adequate therapy in order to achieve the best possible aesthetic and functional result when covering multiple adjacent gingival recessions, reduce postoperative pain, but also ensure an adequate cost-benefit ratio for the patient.

Being tested
Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only
Keywords
periodontal surgery, hyaluronic acid, coronally advanced flap
Medical subject headings
Gingival Recession

What participants receive

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

  • Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap onlyProcedure or surgery

    The potential benefit of adding hyaluronic acid (HA) to the coronally advanced flap (CAF) operative technique to cover multiple adjacent recessions has not been sufficiently investigated. Improving aesthetics is one of the primary goals of root recession coverage periodontal surgery, and little is known about the same in multiple adjacent gingival recession coverage therapy. In patients with a sufficient amount (≥2 mm) of keratinized tissue, the coronally advanced flap (CAF) has been shown to be very effective in the treatment of multiple recessions, especially in terms of aesthetic results. The researchers concluded from a database search (Epistemonikos, Cochrane, Medline) that there is no evidence to support the use of HA + CAF to achieve greater root coverage in the treatment of multiple gingival recessions.

Study groups in NCT06330662
Study groupRoleWhat they receive
Coronally advanced flap with the hyaluronic acidExperimentalThe experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF+HA).
Receives: Procedure: Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only
Coronally advanced flapOtherThe control group refers to surgical intervention using a coronally advanced flap only to cover multiple gingival recessions without the addition of hyaluronic acid (CAF).
Receives: Procedure: Testing the effectiveness of hyaluronic acid in experimental group using a coronally advanced flap compared to a control group using a coronally advanced flap only

What is being measured

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

  1. The effect of hyaluronic acid on recession reduction

    The primary outcome is to examine the effectiveness of hyaluronic acid on the percentage of root coverage when treating multiple adjacent gingival recessions with the coronally advanced flap surgical technique

    Measured: 1 year

Secondary outcomes (11)
  1. To examine the effect of tissue thickness on recession coverage (KTt)

    The thickness of the keratinized tissue will be measured intraoperatively at each teeth midline point from vestibular part of keratinized tissue during flap elevation using a digital caliper (Fervi® monoblock stainless steel electronic digital caliper Art. C041/150 0.01 mm)

    Measured: 1 year

  2. To examine keratinized gingiva width (KTw)

    The width of the keratinized gingiva will be measured intraorally using a periodontal probe (UNC 15, Hu Friedy®,Chicago IL, SAD) baseline and at follow-up examinations after 1 month, 3 months and 6 months postoperatively

    Measured: 1 year

  3. To examine changes in periodontal clinical parameters: PPD

    periodontal pocket probing depth (PPD) is the distance from the gingival margin to the apical portion of the gingival sulcus and will be measured at 3 points; mesial, buccal, distal part of the tooth using a periodontal probe (UNC 15, Hu Friedy®,Chicago IL, SAD) at baseline and follow-up examinations after 3 months and 6 months postoperatively

    Measured: 1 year

  4. To examine changes in periodontal clinical parameters: CAL

    clinical attachment level (CAL) is measured with the periodontal probe (UNC 15, Hu Friedy®,Chicago IL, SAD) as the distance from the cemento-enamel junction (CEJ) to the free gingival margin at baseline and follow-up examinations 3 months and 6 months postoperatively

    Measured: 1 year

  5. To examine changes in periodontal clinical parameters: REC

    Gingival recession is measured clinically as the distance from the cemento-enamel junction to the depth of the free gingival margin using the millimeter markings on the periodontal probe (UNC 15, Hu Friedy®,Chicago IL, SAD) baseline and at follow-up examinations after 1 month, 3 months and 6 months postoperatively

    Measured: 1 year

  6. To examine changes in periodontal clinical parameters: FMPS (full mouth plaque score)

    The presence of plaque will be measured at baseline and at follow-up examinations using a periodontal probe (UNC 15, Hu Friedy®, Chicago IL, USA) at 3 vestibular sites; mesial, buccal, distal. It is recorded using the value + or - and it is calculated afterwards as the number of tooth sites where plaque is recorded, divided by a total number of available sites multiplied by 100 (expressed as a percentage) baseline and at follow-up examinations after 1 month, 3 months and 6 months postoperatively

    Measured: 1 year

  7. To examine changes in periodontal clinical parameters: FMBS (full mouth bleeding score)

    The presence of bleeding sites will be measured at baseline and at follow-up examinations using a periodontal probe (UNC 15, Hu Friedy®, Chicago IL, USA) at 3 vestibular sites; mesial, buccal, distal after the PPD (periodontal pocket depth) measurements. Presence or absence of bleeding will be marked using a value of + or -. The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage baseline and at follow-up examinations after 1 month, 3 months and 6 months postoperatively

    Measured: 1 year

  8. Assess the healing quality of the operated area by using a RES scale

    RES scale (eng. Root coverage esthetic score) in 5 categories;

    • changes evaluated based on the position of the gingival margin (GM); score 0,3,6
    • evaluation of marginal tissue contour changes (MTC); score 0 or 1
    • soft tissue texture evaluation (STT); score 0 or 1
    • evaluation of the alignment of the mucogingival junction (MGJ); score 0 or 1
    • gingival color evaluation (GC); score 0 or 1

    Measured: 1 year

  9. Schiff test tooth examination

    To assess tooth hypersensitivity (scale from 0 to 3) on vestibular surface of the tooth; It is determined by using an air stimulus from the dental unit in such way that the air is directed at an angle of 90 degrees to the vestibular surface of the tooth for 1 second duration from a distance of 1 centimeter. Adjacent teeth are protected with gloves on fingers. Score 0; the patient does not respond to the air stimulus, Score 1; the patient responds to the air stimulus but does not require interruption of the stimulus, Score 2; the patient reacts to the air stimulus and requires interruption or spontaneously withdraws from the stimulus, Score 3; the patient reacts to the stimulus, considers it painful and requests its termination.

    Measured: 1 year

  10. To examine the impact of oral health on quality of life

    Using the OHIP-14 questionnaire; it has been used to assess the impact of oral health problems on an individual's life. It consists of 14 questions, and patients complete it at baseline and at follow-up appointments 1 month, 3 months, 6 months postoperatively. Patients answer the offered 14 questions by circling the stated values: 0; never, 1; almost never, 2; occasionally, 3; often, 4; very often. OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. Higher OHIP-14 scores indicate worse, and lower scores indicate better OHRQol (Oral Health-related Quality of Life)

    Measured: 1 year

  11. To evaluate the level of pain postoperatively during the healing of the surgical wound

    By using the VAS scale and keeping a pain diary during the first 7 days postoperatively.

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a line with graphical display and two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Patients will take the printed measurements scales with them at home and will be asked to mark pain intensity on the scale for the first seven days. Patients will also keep a pain diary where they will be asked to write the name of a painkiller they took, dosage, frequency of taking it and indication. The completed medication diary and the VAS scale are brought with them to the appointment 14 days after the surgery.

    Measured: 1 year

Timeline

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

  1. First posted26 Mar 2024
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Jun 2025 (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
Model description
The control group refers to surgical intervention using a coronally advanced flap to cover multiple gingival recessions without the addition of hyaluronic acid (CAF) and the experimental group indicates the surgical intervention using a coronally advanced flap to cover multiple adjacent gingival recessions with the addition of hyaluronic acid intraoperatively (CAF + HA).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06330662
Sponsor's protocol ID
05-PA-30-19-6/2023.
Status last verified
Mar 2024
First submitted
11 Mar 2024
Last updated
26 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study of Gingival Recession, run by Andelina Sekelja at 1 site in Croatia.

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 8 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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 Croatia. 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?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of hyaluronic acid on recession reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 26 Mar 2024.

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