- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05196490
Analyzing the Effect of Air Polishing on Tooth Surfaces With Two Imaging Methods
Analyzing the Effect of Sodium Bicarbonate and Glycine Air Polishing on Tooth Surfaces With Two Different Imaging Methods
Přehled studie
Detailní popis
The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry. The teeth samples were collected from the participants who have a single-rooted tooth with the gingival recession on all surfaces and need to be extracted. All patients who met the criteria were informed about the study. Patients who gave written informed consent were included. Before the teeth extractions, root surfaces were marked with a bur at the level of the gingival margin. Extractions were performed under local anesthesia with 2% xylocaine adrenalin. Fourteen single root extracted teeth were included into the study. The crown and exposed root surface were air polished using glycine and sodium bicarbonate powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree.
Samples were scanned before and after air polishing with a high-resolution micro-CT device. The scanning conditions were 100 kVp; 100-mA, 0.5-mm Al/Cu filter; 13.1-μm pixel size; and rotation at 0.2 steps. According to the manufacturer's instructions, each sample was rotated 360°. The mean scanning time was around 1hour. The teeth surfaces were digitalized before and after air polishing with an intraoral scanner. The mean scanning time was around 10 second. The virtual images of the scanned teeth were saved in stereolithography (STL) format. The defect volume was estimated.
The data were analyzed using commercially available statistical analysis software. Descriptive statistics that were used to analyze the results included the mean, standard deviation, median, minimum, and maximum. Mann-Whitney U test was performed to compare differences between two independent variables. Wilcoxon test was used to compare differences between two dependent variables. P-values less than 0.05 were considered statistically significant.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Kocaeli, Krocan, 41190
- Kocaeli University, Faculty of Dentistry
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
Being older than age of 18, Willing to participate the study, To have a single rooted tooth with gingival recession on all surfaces and need to be extracted, The tooth has to be free of caries, defects and restorations.
Exclusion Criteria:
Have history of infectious diseases like Hepatitis and/or HIV (+).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Micro-CT
Samples were scanned before and after air polishing with a high-resolution micro-CT device.
The scanning conditions were 100 kVp; 100-mA, 0.5-mm Al/Cu filter; 13.1-μm pixel size; and rotation at 0.2 steps.
According to the manufacturer's instructions, each sample was rotated 360°.
The mean scanning time was around 1hour.
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Micro computed tomography (micro-CT) is an imaging method in which cross-sectional images are obtained and these images are transferred to the computer through specific software, processed and stored.
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CAD/CAM
The teeth surfaces were digitalized before and after air polishing with an intraoral scanner.
The mean scanning time was around 10 second.
The virtual images of the scanned teeth were saved in stereolithography (STL) format.
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CAD/CAM (computer aided design-computer aided manufacturing) is a production method that is frequently used in many areas of technology.
These systems are composed of a data acquisition unit, software for designing virtual restoration, and a computerized milling device.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Defect volume
Časové okno: 5 second
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The teeth were divided into two groups, the crown and exposed root surface were air polished using glycine and sodium bicarbonate powders at instrumentation time of 5s, combinations of medium and maximum power and medium water settings, distance of 5mm and angulation of 60 degree.
Samples were scanned in a micro-computed tomography (micro-CT) and CAD/CAM at baseline and then after powder treatment and the defect volume was estimated.
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5 second
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KOU GOKAEK 2020/08.07
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