- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366385
OccluSense is Sensor Based System Used as a Digital Method for Occlusal Contact Analysis, and Basically Used Without Any Support of Its Sensor. Therefore the Aim of This Study is to Clinically Evaluate the Validity of a Customizable Stabilizing Tray to Support OccluSense Sensor in.
January 23, 2026 updated by: Hala Zakaria, Cairo University
Clinical Evaluation of the Validity of Occlusal Contact Area Measurement Using OccluSense With Versus Without Customizable Stabilizing Tray
Background: Occlusal contacts analysis is of prime importance in order to perform an effective prosthetic restoration.
Quantitative methods for occlusal contact analysis involve using digital systems to measure and analyze occlusal contacts and forces with greater precision than traditional methods.
One of these devices is the OccluSense which is sensor based system and basically used without any support of its sensor.
Therefore the aim of this study is to clinically evaluate the validity of a customizable stabilizing tray to support the sensor of the OccluSense intraoral.
A total of 22 healthy dental students, aged from 18-25 years, are recruited.
Each participant will undergo two set of recordings; firstly by the OccluSense without centering tray then with the tray seated intraoral.
Occlusal contacts were recorded under maximum bite force and Maximum Intercuspation Position (MIP).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manyal
-
Cairo, Manyal, Egypt, 11553
- Faculty of Dentistry Cairo University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- intact arches, no missing teeth, and no TMD disorder.
Exclusion Criteria:
- patients with less than 24 natural teeth, the presence of active orthodontic treatment, as it could interfere with the data acquisition process, the presence of fixed restorations, severe malocclusion, and those with orofacial pain.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: osscluSense with customized centering tray
occlusal contacts was recoded using the osscluSense with customized centering tray
|
A customizable centering tray is a thermoplastic or 3D-printed tray designed to hold the OccluSense sensor straight and centered between arches
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total number of occlusal contacts recorded by the device
Time Frame: this study has unique characteristics. Each participant underwent two set of occlusal recordings with one week interval between the intervention and control toto minimize the risk of muscle fatigue. the outcomes were measured and analyzed instantly
|
this study has unique characteristics. Each participant underwent two set of occlusal recordings with one week interval between the intervention and control toto minimize the risk of muscle fatigue. the outcomes were measured and analyzed instantly
|
|
total contact area and the Number of contact points
Time Frame: two visits with one week interval
|
two visits with one week interval
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Amin BK, Sedeeq HY. The Accuracy of Occlusal Analysis of Intraoral Scanner, Occlusense and Articulating Paper - A Comparative Study. Preprints [Internet]. 2025 Jul; Available from: https://doi.org/10.20944/preprints202507.1837.v1
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2025
Primary Completion (Actual)
September 30, 2025
Study Completion (Actual)
November 30, 2025
Study Registration Dates
First Submitted
January 16, 2026
First Submitted That Met QC Criteria
January 23, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 23, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 41-9-25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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