- ICH GCP
- US-Register für klinische Studien
- Klinische 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
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Kocaeli, Truthahn, 41190
- Kocaeli University, Faculty of Dentistry
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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 (+).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Defect volume
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KOU GOKAEK 2020/08.07
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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