- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07403006
Wpływ kondycjonowania powierzchni korzenia za pomocą polerowania powietrzem erytrytolem i ręcznej instrumentacji na pokrycie recesji przy użyciu zmodyfikowanej techniki tunelowej i podnabłonkowego przeszczepu tkanki łącznej.
Wpływ kondycjonowania powierzchni korzenia za pomocą polerowania powietrzem erytrytolem w porównaniu z ręcznym opracowaniem instrumentami na pokrycie recesji przy zastosowaniu zmodyfikowanej techniki tunelowej i przeszczepu tkanki łącznej nabłonkowej: randomizowane badanie kliniczne
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Magdalena Latkowska - Wiśniewska
- Numer telefonu: +48691470290
- E-mail: magda.latko@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Bartłomiej Górski
- E-mail: gorskibartlomiej04@gmail.com
Lokalizacje studiów
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Mazowsze
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Warsaw, Mazowsze, Polska, 00-246
- Rekrutacyjny
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mean Root Coverage (MRC, %)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Gingival recession height (GRH, mm)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
|
Probing Pocket Depth (PPD, mm)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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, %)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Procedure-related stress (VAS, 0-10)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- WUM.Perio.06
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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