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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months and 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 6 months, and 12 months post-surgery |
| Gingival recession width (RW, mm) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related stress (VAS, 0-10) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magdalena Latkowska - Wiśniewska | Contact | +48691470290 | magda.latko@gmail.com | |
| Bartłomiej Górski | Contact | 0048221166431 | gorskibartlomiej04@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bartłomiej Górski | Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw | Recruiting | Warsaw | Mazowsze | 00-246 | Poland |
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| 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. |
|
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) | 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) | Distance from the gingival margin to the bottom of the gingival sulcus. | 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. | baseline, 6 months, and 12 months post-surgery |
| Keratinized tissue width (KTW, mm) | Distance from the gingival margin to the mucogingival junction | 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. | 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 | 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 | 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 | 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
| 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:
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) | 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) | 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) | 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) | 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) | 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) | 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) | Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent). | 6 and 12 months post-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) | 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) | Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question. | 12 months after surgery |
| ID | Term |
|---|---|
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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