Impatto del Condizionamento della Superficie Radicolare con la Levigatura ad Aria con Eritritolo e la Strumentazione Manuale sulla Copertura della Recessione Utilizzando la Tecnica del Tunnel Modificata e l'Innesto di Tessuto Connettivo Subepiteliale.
Impatto del Condizionamento della Superficie Radicolare con Levigatura ad Aria con Eritritolo rispetto alla Strumentazione Manuale sulla Copertura della Recessione Utilizzando la Tecnica del Tunnel Modificata e l'Innesto di Tessuto Connettivo Subepiteliale: Uno Studio Clinico Randomizzato
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Magdalena Latkowska - Wiśniewska
- Numero di telefono: +48691470290
- Email: magda.latko@gmail.com
Backup dei contatti dello studio
- Nome: Bartłomiej Górski
- Email: gorskibartlomiej04@gmail.com
Luoghi di studio
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Mazowsze
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Warsaw, Mazowsze, Polonia, 00-246
- Reclutamento
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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. |
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. |
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Comparatore attivo: 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. |
Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mean Root Coverage (MRC, %)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Gingival recession height (GRH, mm)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
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Probing Pocket Depth (PPD, mm)
Lasso di tempo: 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)
Lasso di tempo: 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
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Keratinized tissue width (KTW, mm)
Lasso di tempo: 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
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Complete Root Coverage (CRC, %)
Lasso di tempo: 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
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Gingival Recession Reduction (GR red, mm)
Lasso di tempo: 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
|
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Clinical Attachment Level Gain (CAL Gain, mm)
Lasso di tempo: 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
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Keratinized Tissue Width Gain (KTW Gain, mm)
Lasso di tempo: 6 months and 12 months post-surgery
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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
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Tooth Sensitivity (SEN, Schiff score)
Lasso di tempo: 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
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Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
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Root Esthetic Score (RES, score)
Lasso di tempo: 6 and 12 months after surgery
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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
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Discomfort during the procedure (VAS, 0-10)
Lasso di tempo: Immediately after completion of the procedure
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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
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Pain intensity (VAS scale, 0-10)
Lasso di tempo: 1, 2, 4, 7, 14 days after procedure
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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
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Postoperative swelling (VAS scale, 0-10)
Lasso di tempo: 1, 2, 4, 7, 14 days after procedure
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Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum). |
1, 2, 4, 7, 14 days after procedure
|
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Tooth sensitivity (VAS, 0-10)
Lasso di tempo: 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
|
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Gingival color (VAS, 0-10)
Lasso di tempo: 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
|
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Gingival shape (VAS 0-10)
Lasso di tempo: 6 and 12 months post-surgery
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Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent) |
6 and 12 months post-surgery
|
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Tooth appearance (VAS, 0-10)
Lasso di tempo: 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
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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Procedure-related stress (VAS, 0-10)
Lasso di tempo: 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)
|
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Treatment satisfaction (VAS, 0-10)
Lasso di tempo: 12 months after surgery
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Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied). |
12 months after surgery
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Willingness to choose the treatment again (yes/no)
Lasso di tempo: 12 months after surgery
|
Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question. |
12 months after surgery
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Willingness to recommend the treatment (yes/no)
Lasso di tempo: 12 months after surgery
|
Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question. |
12 months after surgery
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Cattedra di studio: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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Maggiori informazioni
Termini relativi a questo studio
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Altri numeri di identificazione dello studio
- WUM.Perio.06
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