Dental OcclusionNCT04798729
Comparison of Two Different Digital Methods in Occlusal Analysis
An observational study of Dental Occlusion and Occlusion, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to compare the T-Scan digital occlusal analysis system and the occlusal analysis mode of the CEREC Omnicam system, which is mainly used for design/ production, using the data recorded at the centric occlusion position. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Occlusion, Occlusion, Jaw Relationship
- What is being tested?
- Digital Occlusal Recording with T-Scan and Digital Occlusal Recording with Cerec Omnicam
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 21 May 2019
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The groups were formed of voluntary participants from undergraduate and postgraduate students in the Dentistry Faculty of Gazi University.
Who may be able to join
- Individuals with no missing teeth (teeth numbers 18, 28, 38, 48 were excluded from the evaluation), no local or systemic disorders that could prevent the bite, and no disorder determined as a result of the TMJ examination.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Faculty of Dentistry
Ankara, 06510
About this study
Official title: COMPARISON OF SENTRIC OCCLUSION DATA OBTAINED FROM TWO DIFFERENT COMPUTER-ASSISTED RECORDING METHODS
Aim: The aim of this study is to compare the T-Scan digital occlusal analysis system and the occlusal analysis mode of the CEREC Omnicam system, which is mainly used for design/ production, using the data recorded at the centric occlusion position.
Material-Method: Occlusal recordings were obtained from healthy 20 females and 20 males aged 18-25 at the centric occlusion position. Records were saved as .jpeg format and transferred to Adobe Photoshop CS6 program. Blue, green, and red colors (shown by the same color codes in both systems) representing light, intense and tight contacts, respectively, were evaluated in terms of the pixel counts. For statistical comparison the differences between the systems Independent Sample T-Test and, between the genders, One Sample T- Test were used (α = 0.05).
- Being tested
- Digital Occlusal Recording with T-Scan, Digital Occlusal Recording with Cerec Omnicam
- Keywords
- Dental Occlusion, Centric Occlusion, Occlusal Analysis, T-Scan, Cerec Omnicam, Digital Dentistry
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Occlusal Recording with T-ScanDevice
Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the T-Scan (T-Scan III, version 9.1, Tekscan Inc., South Boston, USA).
Digital Occlusal Recording with Cerec OmnicamDevice
Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the CEREC Omnicam™ (version 4.2, Sirona Dental Systems, New York, USA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the levels of accuracy of the occlusal analysis mode included in the software of CEREC Omnicam and the T-Scan occlusal analysis system.
In both systems, the data of contact intensity were defined with a color scale of blue to red where blue showed the lowest intensity and red the highest. The contact area images obtained from both systems were recorded in .jpeg format and were then transferred to the Adobe Photoshop CS6 program (Adobe Systems, USA) for comparisons to be made.
The number of pixels in the contact areas of the upper and lower jaws of each subject in all the recordings obtained with the T-Scan and CEREC Omnicam systems were determined using the Adobe Photoshop CS6 pixel-based photographic procedure program.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start2 Jan 2019
- Primary completion22 Feb 2019
- Study completion21 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental OcclusionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evsen Tamam, Gazi University
- Investigators
- Evsen TAMAM, Phd, DDS, Assoc Prof Dr, Study chair, Gazi University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798729
- Sponsor's protocol ID
- 2017-419
- Status last verified
- Mar 2021
- First submitted
- 5 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Individual data sharing
- Yes: It is planned to publish all the collected data as an article in a well-known journal.
Publications
Bostancioglu SE, Togay A, Tamam E. Comparison of two different digital occlusal analysis methods. Clin Oral Investig. 2022 Feb;26(2):2095-2109. doi: 10.1007/s00784-021-04191-1. Epub 2021 Oct 1.
PubMed 34596770
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF SENTRIC OCCLUSION DATA OBTAINED FROM TWO DIFFERENT COMPUTER-ASSISTED RECORDING METHODS
- ClinicalTrials.gov ID
- NCT04798729
- Acronym / sponsor ID
- 2017-419
- Keywords
- Dental Occlusion, Centric Occlusion, Occlusal Analysis, T-Scan, Cerec Omnicam, Digital Dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 15 Mar 2021 (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.
Aim: The aim of this study is to compare the T-Scan digital occlusal analysis system and the occlusal analysis mode of the CEREC Omnicam system, which is mainly used for design/ production, using the data recorded at the centric occlusion position.
Material-Method: Occlusal recordings were obtained from healthy 20 females and 20 males aged 18-25 at the centric occlusion position. Records were saved as .jpeg format and transferred to Adobe Photoshop CS6 program. Blue, green, and red colors (shown by the same color codes in both systems) representing light, intense and tight contacts, respectively, were evaluated in terms of the pixel counts. For statistical comparison the differences between the systems Independent Sample T-Test and, between the genders, One Sample T- Test were used (α = 0.05).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The groups were formed of voluntary participants from undergraduate and postgraduate students in the Dentistry Faculty of Gazi University.
Key inclusion criteria (1 listed)
- Individuals with no missing teeth (teeth numbers 18, 28, 38, 48 were excluded from the evaluation), no local or systemic disorders that could prevent the bite, and no disorder determined as a result of the TMJ examination.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Digital Occlusal Recording with T-ScanOcclusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the T-Scan (T-Scan III, version 9.1, Tekscan Inc., South Boston, USA). | Device | – |
| Digital Occlusal Recording with Cerec OmnicamOcclusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the CEREC Omnicam™ (version 4.2, Sirona Dental Systems, New York, USA). | Device | – |
Primary outcome
Comparing the levels of accuracy of the occlusal analysis mode included in the software of CEREC Omnicam and the T-Scan occlusal analysis system.
Time frame: 6 months
In both systems, the data of contact intensity were defined with a color scale of blue to red where blue showed the lowest intensity and red the highest. The contact area images obtained from both systems were recorded in .jpeg format and were then transferred to the Adobe Photoshop CS6 program (Adobe Systems, USA) for comparisons to be made. The number of pixels in the contact areas of the upper and lower jaws of each subject in all the recordings obtained with the T-Scan and CEREC Omnicam systems were determined using the Adobe Photoshop CS6 pixel-based photographic procedure program.
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 17 Mar 2021.
- Derived from this study: PubMed 34596770Bostancioglu SE, Togay A, Tamam E. Comparison of two different digital occlusal analysis methods. Clin Oral Investig. 2022 Feb;26(2):2095-2109. doi: 10.1007/s00784-021-04191-1. Epub 2021 Oct 1.
- Individual participant dataSharing planned: Yes. It is planned to publish all the collected data as an article in a well-known journal.
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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.
Evsen TAMAM, Phd, DDS, Assoc Prof Dr study chair
Gazi University Faculty of Dentistry
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 Occlusion and Occlusion, run by Gazi 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 17 Mar 2021. 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?
Comparing the levels of accuracy of the occlusal analysis mode included in the software of CEREC Omnicam and the T-Scan occlusal analysis system. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798729, which also lists 1 linked publication.
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 17 Mar 2021.