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.

March 9, 2026 updated by: Medical University of Warsaw

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Mazowsze
      • Warsaw, Mazowsze, Poland, 00-246
        • Recruiting
        • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erythritol Air-Polishing
Sites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.
Procedure: Erythritol Air-Polishing
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.
Active Comparator: Manual Root Instrumentation
Sites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.
Procedure: Manual Root Instrumentation
Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival recession height (GRH, mm)
Time Frame: baseline, 6 months, and 12 months post-surgery
Distance from the cemento-enamel junction (CEJ) to the gingival margin measured at the mid-buccal aspect of the tooth.
baseline, 6 months, and 12 months post-surgery
Gingival recession width (RW, mm)
Time Frame: baseline, 6 months, and 12 months post-surgery
Horizontal distance measured at the level of the cemento-enamel junction (CEJ) between the mesial and distal margins of the gingival recession.
baseline, 6 months, and 12 months post-surgery
Clinical Attachment Level (CAL, mm)
Time Frame: Baseline; 6 and 12 months post-surgery
Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus.
Baseline; 6 and 12 months post-surgery
Probing Pocket Depth (PPD, mm)
Time Frame: baseline, 6 months, and 12 months post-surgery
Distance from the gingival margin to the bottom of the gingival sulcus.
baseline, 6 months, and 12 months post-surgery
Gingival Thickness (GT, mm)
Time Frame: baseline, 6 months, and 12 months post-surgery
Thickness of the gingiva measured 3 mm apical to the gingival margin at the mid-buccal aspect of the tooth.
baseline, 6 months, and 12 months post-surgery
Keratinized tissue width (KTW, mm)
Time Frame: baseline, 6 months, and 12 months post-surgery
Distance from the gingival margin to the mucogingival junction
baseline, 6 months, and 12 months post-surgery
Complete Root Coverage (CRC, %)
Time Frame: 6 months and 12 months post-surgery

% 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.
6 months and 12 months post-surgery
Gingival Recession Reduction (GR red, mm)
Time Frame: 6 months and 12 months post-surgery
Reduction in recession height at 6 months: GR₀ - GR₆ Reduction in recession height at 12 months: GR₀ - GR₁₂
6 months and 12 months post-surgery
Clinical Attachment Level Gain (CAL Gain, mm)
Time Frame: 6 months and 12 months post-surgery

Clinical attachment level gain at 6 months = CAL₀ - CAL₆

Clinical attachment level gain at 12 months = CAL₀ - CAL₁₂
6 months and 12 months post-surgery
Keratinized Tissue Width Gain (KTW Gain, mm)
Time Frame: 6 months and 12 months post-surgery
Increase in keratinized tissue width at 6 months: KTW₆ - KTW₀ Increase in keratinized tissue width at 12 months: KTW₁₂ - KTW₀
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.

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
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

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.
6 and 12 months after surgery
Discomfort during the procedure (VAS, 0-10)
Time Frame: Immediately after completion of the procedure
Patient-reported discomfort during the procedure assessed using the Visual Analogue Scale (VAS; 0 = no discomfort, 10 = extreme discomfort).
Immediately after completion of the procedure
Pain intensity (VAS scale, 0-10)
Time Frame: 1, 2, 4, 7, 14 days after procedure
Patient-reported pain intensity assessed using the Visual Analogue Scale (VAS; 0 = no pain, 10 = maximum pain).
1, 2, 4, 7, 14 days after procedure
Postoperative swelling (VAS scale, 0-10)
Time Frame: 1, 2, 4, 7, 14 days after procedure
Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).
1, 2, 4, 7, 14 days after procedure
Tooth sensitivity (VAS, 0-10)
Time Frame: 1, 2, 4, 7, and 14 days post-procedure
Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).
1, 2, 4, 7, and 14 days post-procedure
Gingival color (VAS, 0-10)
Time Frame: 6 and 12 months post-surgery
Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).
6 and 12 months post-surgery
Gingival shape (VAS 0-10)
Time Frame: 6 and 12 months post-surgery
Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent)
6 and 12 months post-surgery
Tooth appearance (VAS, 0-10)
Time Frame: 6 and 12 months post-surgery
Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).
6 and 12 months post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related stress (VAS, 0-10)
Time Frame: Baseline (day of surgery, pre-anesthesia)
Patient-reported procedure-related stress assessed using the Visual Analogue Scale (VAS; 0 = no stress, 10 = extreme stress).
Baseline (day of surgery, pre-anesthesia)
Treatment satisfaction (VAS, 0-10)
Time Frame: 12 months after surgery
Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied).
12 months after surgery
Willingness to choose the treatment again (yes/no)
Time Frame: 12 months after surgery
Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question.
12 months after surgery
Willingness to recommend the treatment (yes/no)
Time Frame: 12 months after surgery
Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question.
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUM.Perio.06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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