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NCT Number: NCT07403006

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.

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Warsaw, Mazowsze, 00-246, Poland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythritol Air-Polishing

Procedure

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 Instrumentation

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Keratinized tissue width (KTW, mm)

    Time frame: baseline, 6 months, and 12 months post-surgery

    Distance from the gingival margin to the mucogingival junction

  7. 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.

  8. 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

  9. 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

  10. 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

  11. 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

    • = 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
  12. 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:

    • 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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)

  19. 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).

Other outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bartłomiej Górski

CONTACT

[email protected]

Magdalena Latkowska - Wiśniewska

CONTACT

[email protected]

+48691470290

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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