Dental PlaqueNCT05196490
Analyzing the Effect of Air Polishing on Tooth Surfaces With Two Imaging Methods
An observational study of Dental Plaque, run by Kocaeli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Micro-CT and CAD/CAM
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2020to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.
Who may be able to join
- 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.
Who cannot join
- Have history of infectious diseases like Hepatitis and/or HIV (+).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University, Faculty of Dentistry
Kocaeli, 41190
About this study
Official title: Analyzing the Effect of Sodium Bicarbonate and Glycine Air Polishing on Tooth Surfaces With Two Different Imaging Methods
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.
Read the detailed 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.
- Conditions
- Dental Plaque
- Being tested
- Micro-CT, CAD/CAM
- Keywords
- computer-aided design, X-Ray microtomography, sodium bicarbonate, glycine, air abrasion
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CAD/CAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start17 Jun 2020
- Primary completion17 Aug 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vecihe Merve Balta Uysal, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196490
- Sponsor's protocol ID
- KOU GOKAEK 2020/08.07
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing the Effect of Sodium Bicarbonate and Glycine Air Polishing on Tooth Surfaces With Two Different Imaging Methods
- ClinicalTrials.gov ID
- NCT05196490
- Acronym / sponsor ID
- KOU GOKAEK 2020/08.07
- Conditions
- Dental Plaque
- Keywords
- computer-aided design, X-Ray microtomography, sodium bicarbonate, glycine, air abrasion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-CT | – | Device: Micro-CTSamples 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. |
| CAD/CAM | – | Device: CAD/CAMThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients were recruited from individuals seeking periodontal and/or dental treatment at Kocaeli University, Faculty of Dentistry.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Have history of infectious diseases like Hepatitis and/or HIV (+).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-CTMicro 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. | Device | Micro-CT |
| CAD/CAMCAD/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. | Device | CAD/CAM |
Primary outcome
Defect volume
Time frame: 5 second
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defect volume (time frame: 5 second). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.