NCT04798729

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 5, 2021

Last Update Submit

March 15, 2021

Conditions

Keywords

Dental OcclusionCentric OcclusionOcclusal AnalysisT-ScanCerec OmnicamDigital Dentistry

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Interventions

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).

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).

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsA total of 20 males and 20 females were included in the study, all aged 18-25 years, 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.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The groups were formed of voluntary participants from undergraduate and postgraduate students in the Dentistry Faculty of Gazi University.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Dentistry

Ankara, 06510, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Evsen TAMAM, Phd, DDS, Assoc Prof Dr

    Gazi University Faculty of Dentistry

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof Dr, Clinical Professor

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 15, 2021

Study Start

January 2, 2019

Primary Completion

February 22, 2019

Study Completion

May 21, 2019

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

It is planned to publish all the collected data as an article in a well-known journal.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The study has already been prepared to submit to a journal. It is requested to be published on condition that it is accepted.

Locations