- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07403006
Dopad kondicionování kořenového povrchu pomocí air-polishing s erythritolem a ruční instrumentace na krytí recese s využitím modifikované tunelové techniky a subepiteliálního pojivového štěpu.
Vliv úpravy kořenového povrchu pomocí air-polishingu s erytritolem versus ruční instrumentace na pokrytí recese s využitím modifikované tunelové techniky a subepiteliálního vazivového štěpu: Randomizovaná klinická studie
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Magdalena Latkowska - Wiśniewska
- Telefonní číslo: +48691470290
- E-mail: magda.latko@gmail.com
Studijní záloha kontaktů
- Jméno: Bartłomiej Górski
- E-mail: gorskibartlomiej04@gmail.com
Studijní místa
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Mazowsze
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Warsaw, Mazowsze, Polsko, 00-246
- Nábor
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Aktivní komparátor: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Root Coverage (MRC, %)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gingival recession height (GRH, mm)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
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Gingival Thickness (GT, mm)
Časové okno: 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)
Časové okno: 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, %)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
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Tooth Sensitivity (SEN, Schiff score)
Časové okno: 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)
Časové okno: 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:
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)
Časové okno: 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
|
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Pain intensity (VAS scale, 0-10)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
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Tooth appearance (VAS, 0-10)
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Procedure-related stress (VAS, 0-10)
Časové okno: Baseline (day of surgery, pre-anesthesia)
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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)
Časové okno: 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
|
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Willingness to choose the treatment again (yes/no)
Časové okno: 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)
Časové okno: 12 months after surgery
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Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question. |
12 months after surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WUM.Perio.06
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