AzTrials
AzTrials

Gingival RecessionPhase 1/2NCT07437885

Effects of the Adjunctive Use of Hyaluronic Acid-based Gel With Coranally Advanced Flap in the Gingival Recession

A Phase 1/2 study testing Hyaluronic acid and Steril saline solution in people with Gingival Recession, run by Ordu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aimed to evaluate the effect of Hyaluronic Acid-based gel use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Gingival Recession
What is being tested?
Hyaluronic acid and Steril saline solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2024to 10 Aug 2025
Phase
Phase 1/2
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Double-sided type 1 gingival recession
  • No inflammation

Who cannot join

  • active periodontal disease
  • smokers
  • pregnant and breastfeeding women
  • individuals with unilateral GR

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Figen Öngöz Dede

    Ordu, 52100

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical Efficacy and Patient Experience of Adjunctive Hyaluronic Acid-based Gel Application With Coronally Advanced Flap in Type 1 Gingival Recession: A Randomized Controlled Clinical Trial

The study aimed to evaluate the effect of Hyaluronic Acid-based gel use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

Read the detailed description

The aim of this study is to evaluate the effect of HA use in addition to the coronally advanced flap (CAF) technique in type 1 gingival recession (RT1) on postoperative morbidity, clinical parameters, and patient satisfaction, analyzed at baseline and 6 months.

This split-mouth study included 20 patients (9 males, 11 females) with a mean age of 42.10±9.46 years who were diagnosed with bilateral RT1 gingival recession in the maxilla. The right and left defect areas of the 20 patients were randomly assigned to two groups. The control group received CAF (n=20), and the test group received CAF+HA (n=20). Pre-treatment plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), vertical recession depth (VRD), horizontal recession width (HRW), gingival thickness (GT), attached gingival (AG), and keratinized gingival width (KGW) were recorded. Additionally, a satisfaction analysis was conducted, including patient-based comfort (PBC), aesthetic (PEA), and sensitivity (PHS) scores. During the operation, a 0.8% HA gel was applied to the defect areas in the test group, in addition to CAF, while saline was applied to the control group, also in addition to CAF. Pain, bleeding, and edema scores, as well as the amount of painkillers, were recorded during the 9-day postoperative period. Clinical parameter measurements and patient satisfaction analyses were repeated 6 months after surgical treatment.

Being tested
Hyaluronic acid, Steril saline solution
Medical subject headings
Gingival Recession

What participants receive

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

  • Hyaluronic acidDrug

    0.8% hyaluronic acid gel (Gengigel Oral Forte Gel, Ricefarma, Milan, Italy)

  • Steril saline solutionOther

    Mix 8 teaspoons of salt into 4 L of distilled water

Study groups in NCT07437885
Study groupRoleWhat they receive
Coranally Advanced Flap and Hyaluronic Acid-Based Gel applicationActive comparatorCoronally advanced flap and adjunctive use of 0.8% hyaluronic acid-based gel
Receives: Drug: Hyaluronic acid
Coranally Advanced FlapPlacebo comparatorOnly Coronally advanced flap
Receives: Other: Steril saline solution

What is being measured

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

  1. Complete root coverage

    for evaluating rate of complete root coverage

    Measured: 6 months postsurgery

  2. Mean root coverage

    for evaluating rate of mean root coverage

    Measured: 6 months postsurgery

Secondary outcomes (24)

  1. Plaque Index

    to assess plaque accumulation

    Measured: Baseline

  2. Plaque Index

    to assess plaque accumulation

    Measured: 6 months post surgery

  3. Gingival Index

    for evaluating gingival inflammation

    Measured: Baseline

  4. Gingival index

    for evaluating gingival inflammation

    Measured: 6 montsh post surgery

  5. Probing pocket depth

    for measuring disease severity

    Measured: Baseline

  6. Probing pocket depth

    for measuring disease severity

    Measured: 6 months post surgery

  7. Clinical attachment level

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

    Measured: Baseline

  8. Clinical attachment level

    Clinical attachment level (CAL) is calculated by adding or subtracting probing depth (PD) and gingival recession (GR). The formula is CAL = PD + GR. CAL is measured in millimeters.

    Measured: 6 months post surgery

  9. Vertical recession depth

    for evaluating gingival recession depth

    Measured: Baseline

  10. Vertical recession depth

    for evaluating gingival recession depth

    Measured: 6 months postsurgery

  11. Horizontal gingival recession

    for evaluating gingival recession depth

    Measured: Baseline

  12. Horizontal gingival recession

    for evaluating gingival recession depth

    Measured: 6 months postsurgery

  13. Attached gingival width

    for evaluating attached gingival width

    Measured: Baseline

  14. Attached gingival width

    for evaluating attached gingival width

    Measured: 6 months postsurgery

  15. Keratinized gingival width

    for evaluating keratinized gingival width

    Measured: Baseline

  16. Keratinized gingival width

    for evaluating keratinized gingival width

    Measured: 6 months postsurgery

  17. Gingival thickness

    for evaluating gingival thickness

    Measured: Baseline

  18. Gingival thickness

    for evaluating gingival thickness

    Measured: 6 months postsurgery

  19. Patient comfort score

    Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".

    Measured: Baseline

  20. Patient comfort score

    Patient satisfaction was assessed using a visual analog scale (VAS). "unbearable discomfort (score 0)" to "no discomfort (score 10)".

    Measured: 6 months postsurgery

  21. Patient aesthetic score

    Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale

    Measured: Baseline

  22. Patient aesthetic score

    Poor-unexpected aesthetics (score 0) → beautiful-perfect aesthetics (score 10) using VAS scale

    Measured: 6 months post surgery

  23. Patient sensitivity score

    painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale

    Measured: Baseline

  24. Patient sensitivity score

    painless-discomfort no (score 0) → unbearable pain (score 10) using VAS scale

    Measured: 6 months postsurgery

Timeline

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

  1. First posted27 Feb 2026
  2. Study start1 Sep 2024
  3. Primary completion30 Jul 2025
  4. Study completion10 Aug 2025

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07437885
Sponsor's protocol ID
2024/178
Status last verified
Feb 2026
First submitted
20 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hyaluronic acid and Steril saline solution in people with Gingival Recession, run by Ordu University at 1 site in Turkey (Türkiye).

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 Feb 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Complete root coverage (time frame: 6 months postsurgery). The study lists 2 primary outcomes in all. 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 NCT07437885.

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 27 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in