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AzTrials

Gingival RecessionNCT07403006

Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.

A study testing Erythritol Air-Polishing and Manual Root Instrumentation in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Gingival Recession
What is being tested?
Erythritol Air-Polishing and Manual Root Instrumentation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 sitePoland
Study dates
9 Mar 2026to Jul 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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Multiple RT1 and/or RT2 gingival recessions, symmetrical and bilateral, with a minimum height of ≥ 1 mm
  • Full-mouth plaque score (FMPS) < 15% (assessed on four surfaces per tooth)
  • Full-mouth bleeding on probing (FMBOP) < 15% (assessed on four surfaces per tooth)
  • Detectable cemento-enamel junction (CEJ)
  • Age ≥ 18 years

Who cannot join

  • RT3 gingival recessions
  • Gingival recessions affecting second and third molars
  • Systemic or infectious diseases that may impair wound healing, including active malignancy, diabetes mellitus with HbA1c > 7.0%, history of head and neck radiotherapy, true xerostomia, and HIV/AIDS
  • Cervical caries, non-carious cervical lesions, or Class V restorations interfering with the CEJ
  • Active periodontitis
  • Use of medications affecting periodontal tissues or wound healing, including systemic corticosteroids, immunosuppressants, isotretinoin, bisphosphonates, and monoclonal antibodies with immunosuppressive, antiresorptive, or antiangiogenic effects
  • Smoking
  • Pregnancy or breastfeeding

Trial locations and contacts

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

Magdalena Latkowska - Wiśniewska contact

+48691470290

magda.latko@gmail.com

Bartłomiej Górski contact

gorskibartlomiej04@gmail.com

Poland1 site, 1 recruiting
  • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

    Warsaw, Mazowsze, 00-246

    Recruiting

Other trials in Poland

About this study

Official title: Impact of Root Surface Conditioning With Erythritol Air Polishing Versus Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft: A Randomized Clinical Trial

This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique.

Being tested
Erythritol Air-Polishing, Manual Root Instrumentation
Medical subject headings
Gingival Recession

What participants receive

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

  • Erythritol Air-PolishingProcedure or surgery

    Root surface preparation performed using erythritol powder air-polishing (EMS AIRFLOW PLUS) prior to root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

  • Manual Root InstrumentationProcedure or surgery

    Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

Study groups in NCT07403006
Study groupRoleWhat they receive
Erythritol Air-PolishingExperimentalSites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.
Receives: Procedure: Erythritol Air-Polishing
Manual Root InstrumentationActive comparatorSites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.
Receives: Procedure: Manual Root Instrumentation

What is being measured

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

  1. Mean Root Coverage (MRC, %)

    Mean root coverage (MRC), expressed as a percentage (%), assessed at 6 and 12 months post-surgery.

    MRC is calculated as (GR₀ - GR₆) / GR₀ × 100% and (GR₀ - GR₁₂) / GR₀ × 100%, respectively.

    Gingival recession (GR), measured in millimeters (mm) as the distance from the cemento-enamel junction (CEJ) to the gingival margin at the mid-buccal aspect of the tooth, is used solely as an input parameter for the calculation of MRC.

    Measured: 6 months and 12 months post-surgery

Secondary outcomes (19)
  1. Gingival recession height (GRH, mm)

    Distance from the cemento-enamel junction (CEJ) to the gingival margin measured at the mid-buccal aspect of the tooth.

    Measured: baseline, 6 months, and 12 months post-surgery

  2. Gingival recession width (RW, mm)

    Horizontal distance measured at the level of the cemento-enamel junction (CEJ) between the mesial and distal margins of the gingival recession.

    Measured: baseline, 6 months, and 12 months post-surgery

  3. Clinical Attachment Level (CAL, mm)

    Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus.

    Measured: Baseline; 6 and 12 months post-surgery

  4. Probing Pocket Depth (PPD, mm)

    Distance from the gingival margin to the bottom of the gingival sulcus.

    Measured: baseline, 6 months, and 12 months post-surgery

  5. Gingival Thickness (GT, mm)

    Thickness of the gingiva measured 3 mm apical to the gingival margin at the mid-buccal aspect of the tooth.

    Measured: baseline, 6 months, and 12 months post-surgery

  6. Keratinized tissue width (KTW, mm)

    Distance from the gingival margin to the mucogingival junction

    Measured: baseline, 6 months, and 12 months post-surgery

  7. Complete Root Coverage (CRC, %)

    % CRC = (number of teeth with CRC = 1 after treatment / total number of teeth with gingival recession at baseline) × 100.

    CRC = 1: postoperative GR ≤ 0 mm, indicating complete root coverage. CRC = 0: postoperative GR > 0 mm, indicating partial or no root coverage.

    Measured: 6 months and 12 months post-surgery

  8. Gingival Recession Reduction (GR red, mm)

    Reduction in recession height at 6 months: GR₀ - GR₆ Reduction in recession height at 12 months: GR₀ - GR₁₂

    Measured: 6 months and 12 months post-surgery

  9. Clinical Attachment Level Gain (CAL Gain, mm)

    Clinical attachment level gain at 6 months = CAL₀ - CAL₆

    Clinical attachment level gain at 12 months = CAL₀ - CAL₁₂

    Measured: 6 months and 12 months post-surgery

  10. Keratinized Tissue Width Gain (KTW Gain, mm)

    Increase in keratinized tissue width at 6 months: KTW₆ - KTW₀ Increase in keratinized tissue width at 12 months: KTW₁₂ - KTW₀

    Measured: 6 months and 12 months post-surgery

  11. Tooth Sensitivity (SEN, Schiff score)

    Clinician-assessed tooth sensitivity evaluated using the Schiff Cold Air Sensitivity Scale.

    Air will be delivered using a standard air syringe of the dental unit, positioned approximately 1 cm from the tooth surface for 5 seconds, at a working temperature of 23 °C (±4 °C), and directed at the exposed buccal surface of the tooth with gingival recession.

    Patient response to the air stimulus will be assessed by the clinician using the Schiff Cold Air Sensitivity Scale as follows:

    0 = No response to the air stimulus

    1. = Response to the air stimulus, but no request to discontinue the stimulus
    2. = Response to the air stimulus, with a request to discontinue the stimulus and/or turning away from the stimulus
    3. = Painful response to the air stimulus, with a request to discontinue the stimulus

    Measured: Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.

  12. Root Esthetic Score (RES, score)

    Root Esthetic Score (RES), expressed as a composite score ranging from 0 to 10 points.

    The RES is a clinician-assessed composite esthetic outcome comprising the following five components:

    1. Gingival Margin (GM): failure of root coverage (0 points), partial root coverage (3 points), complete root coverage (6 points);
    2. Marginal Tissue Contour (MTC): irregular gingival margin not following the cemento-enamel junction (CEJ) (0 points), scalloped gingival contour following the CEJ (1 point);
    3. Soft Tissue Texture (STT): presence of scar (0 points), absence of scars (1 point);
    4. Mucogingival Junction (MGJ): MGJ not aligned with the MGJ of adjacent teeth (0 points), MGJ aligned with the MGJ of adjacent teeth (1 point);
    5. Gingival Color (GC): color mismatch with adjacent teeth (0 points), color matching adjacent teeth (1 point).

    The total RES score is calculated as the sum of all component scores, with higher scores indicating a better esthetic outcome.

    Measured: 6 and 12 months after surgery

  13. Discomfort during the procedure (VAS, 0-10)

    Patient-reported discomfort during the procedure assessed using the Visual Analogue Scale (VAS; 0 = no discomfort, 10 = extreme discomfort).

    Measured: Immediately after completion of the procedure

  14. Pain intensity (VAS scale, 0-10)

    Patient-reported pain intensity assessed using the Visual Analogue Scale (VAS; 0 = no pain, 10 = maximum pain).

    Measured: 1, 2, 4, 7, 14 days after procedure

  15. Postoperative swelling (VAS scale, 0-10)

    Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

    Measured: 1, 2, 4, 7, 14 days after procedure

  16. Tooth sensitivity (VAS, 0-10)

    Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

    Measured: 1, 2, 4, 7, and 14 days post-procedure

  17. Gingival color (VAS, 0-10)

    Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

    Measured: 6 and 12 months post-surgery

  18. Gingival shape (VAS 0-10)

    Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent)

    Measured: 6 and 12 months post-surgery

  19. Tooth appearance (VAS, 0-10)

    Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

    Measured: 6 and 12 months post-surgery

Timeline

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

  1. First posted11 Feb 2026
  2. Study start9 Mar 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJul 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
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07403006
Sponsor's protocol ID
WUM.Perio.06
Status last verified
Sep 2026
First submitted
21 Jan 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Erythritol Air-Polishing and Manual Root Instrumentation in people with Gingival Recession, run by Medical University of Warsaw at 1 site in Poland.

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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Poland. 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 Magdalena Latkowska - Wiśniewska (+48691470290, magda.latko@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Root Coverage (MRC, %) (time frame: 6 months and 12 months post-surgery). 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 2 Oct 2026.

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