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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorMedical University of Warsaw

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Erythritol Air-Polishing

    Procedure/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 Instrumentation

    Procedure/Surgery

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Erythritol Air-PolishingExperimental treatment 1 intervention
Group B: Manual Root InstrumentationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
6 months and 12 months post-surgery

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

1

Procedure-related stress (VAS, 0-10)

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

Time frame
Baseline (day of surgery, pre-anesthesia)
2

Treatment satisfaction (VAS, 0-10)

Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied).

Time frame
12 months after surgery
3

Willingness to choose the treatment again (yes/no)

Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question.

Time frame
12 months after surgery
4

Willingness to recommend the treatment (yes/no)

Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question.

Time frame
12 months after surgery

Sponsors and contacts

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