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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05196490
Other study ID # KOU GOKAEK 2020/08.07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 17, 2020
Est. completion date September 14, 2020

Study information

Verified date January 2022
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Micro-CT is a non-destructive imaging method with high resolution and allows to examine all tooth structures individually. Pre- and post-application images obtained by micro-CT can be superimposed and differences can be precisely detected. Intraoral scanners in CAD/CAM systems also provide non-destructive image scanning. CAD/CAM are systems that are widely used in dentistry today. Access to the device is easier than micro-CT. This study was focused on to compare two different imaging methods by assessing changes caused by sodium bicarbonate and glycine air polishing on the tooth surfaces.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date September 14, 2020
Est. primary completion date August 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 (+).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Micro-CT
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.
CAD/CAM
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.

Locations

Country Name City State
Turkey Kocaeli University, Faculty of Dentistry Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Defect volume 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. 5 second
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