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.
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.
Bartłomiej Górski contact
Poland1 site, 1 recruiting
- Recruiting
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Mazowsze, 00-246
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.
- Conditions
- Gingival Recession
- 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 group | Role | What they receive |
|---|---|---|
| Erythritol Air-Polishing | Experimental | Sites 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 Instrumentation | Active comparator | Sites 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.
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)
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
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
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
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
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
Keratinized tissue width (KTW, mm)
Distance from the gingival margin to the mucogingival junction
Measured: baseline, 6 months, and 12 months post-surgery
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
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
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
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
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
- = Response to the air stimulus, but no request to discontinue the stimulus
- = Response to the air stimulus, with a request to discontinue the stimulus and/or turning away from the stimulus
- = 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.
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:
- Gingival Margin (GM): failure of root coverage (0 points), partial root coverage (3 points), complete root coverage (6 points);
- Marginal Tissue Contour (MTC): irregular gingival margin not following the cemento-enamel junction (CEJ) (0 points), scalloped gingival contour following the CEJ (1 point);
- Soft Tissue Texture (STT): presence of scar (0 points), absence of scars (1 point);
- Mucogingival Junction (MGJ): MGJ not aligned with the MGJ of adjacent teeth (0 points), MGJ aligned with the MGJ of adjacent teeth (1 point);
- 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
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
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
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
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
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
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
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.
- First posted11 Feb 2026
- Study start9 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartłomiej Górski, Study chair, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07403006
- Acronym / sponsor ID
- WUM.Perio.06
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythritol Air-Polishing | Experimental | Procedure: Erythritol Air-PolishingSites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft. |
| Manual Root Instrumentation | Active comparator | Procedure: Manual Root InstrumentationSites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erythritol Air-PolishingRoot 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. | Procedure or surgery | Erythritol Air-Polishing |
| Manual Root InstrumentationMechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft. | Procedure or surgery | Manual Root Instrumentation |
Primary outcome
Mean Root Coverage (MRC, %)
Time frame: 6 months and 12 months post-surgery
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.
19 secondary outcomes
Gingival recession height (GRH, mm)
Time frame: baseline, 6 months, and 12 months post-surgery
Gingival recession width (RW, mm)
Time frame: baseline, 6 months, and 12 months post-surgery
Clinical Attachment Level (CAL, mm)
Time frame: Baseline; 6 and 12 months post-surgery
Probing Pocket Depth (PPD, mm)
Time frame: baseline, 6 months, and 12 months post-surgery
Gingival Thickness (GT, mm)
Time frame: baseline, 6 months, and 12 months post-surgery
Keratinized tissue width (KTW, mm)
Time frame: baseline, 6 months, and 12 months post-surgery
Complete Root Coverage (CRC, %)
Time frame: 6 months and 12 months post-surgery
Gingival Recession Reduction (GR red, mm)
Time frame: 6 months and 12 months post-surgery
Clinical Attachment Level Gain (CAL Gain, mm)
Time frame: 6 months and 12 months post-surgery
Keratinized Tissue Width Gain (KTW Gain, mm)
Time frame: 6 months and 12 months post-surgery
Tooth Sensitivity (SEN, Schiff score)
Time frame: Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
Root Esthetic Score (RES, score)
Time frame: 6 and 12 months after surgery
Discomfort during the procedure (VAS, 0-10)
Time frame: Immediately after completion of the procedure
Pain intensity (VAS scale, 0-10)
Time frame: 1, 2, 4, 7, 14 days after procedure
Postoperative swelling (VAS scale, 0-10)
Time frame: 1, 2, 4, 7, 14 days after procedure
Tooth sensitivity (VAS, 0-10)
Time frame: 1, 2, 4, 7, and 14 days post-procedure
Gingival color (VAS, 0-10)
Time frame: 6 and 12 months post-surgery
Gingival shape (VAS 0-10)
Time frame: 6 and 12 months post-surgery
Tooth appearance (VAS, 0-10)
Time frame: 6 and 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Gingival Recession
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Active, not recruiting
Vertically Coronally Advanced Flap Versus Coronally Advanced Flap for Miller Class I Gingival Recession
Gingival Recession
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Recruiting
Effects of Low-Level Laser Therapy and Hyaluronic Acid After Free Gingival Graft
Gingival Recession, Mucogingival Surgery
Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bartłomiej Górski contact
Bartłomiej Górski study chair
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
1 site in 1 country: see every site and its status.
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.