NCT05196490

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 5, 2022

Last Update Submit

January 5, 2022

Conditions

Keywords

computer-aided designX-Ray microtomographysodium bicarbonateglycineair abrasion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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.

Device: Micro-CT

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.

Device: CAD/CAM

Interventions

Micro-CTDEVICE

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.

Micro-CT
CAD/CAMDEVICE

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.

CAD/CAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.

You may qualify if:

  • 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.

You may not qualify if:

  • Have history of infectious diseases like Hepatitis and/or HIV (+).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University, Faculty of Dentistry

Kocaeli, 41190, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

X-Ray Microtomography

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

June 17, 2020

Primary Completion

August 17, 2020

Study Completion

September 14, 2020

Last Updated

January 19, 2022

Record last verified: 2022-01

Locations