NCT07366385

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

September 1, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

29 days

First QC Date

January 16, 2026

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • total number of occlusal contacts recorded by the device

    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

    two visits with one week interval

Study Arms (1)

osscluSense with customized centering tray

EXPERIMENTAL

occlusal contacts was recoded using the osscluSense with customized centering tray

Device: osscluSense with customized centering tray

Interventions

A customizable centering tray is a thermoplastic or 3D-printed tray designed to hold the OccluSense sensor straight and centered between arches

osscluSense with customized centering tray

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- intact arches, no missing teeth, and no TMD disorder.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry Cairo University

Cairo, Manyal, 11553, Egypt

Location

Related Publications (1)

  • 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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 22 healthy dental students, all aged from 18-25 years, was recruited on a voluntary basis, from the faculty of dentistry Cairo University with the following inclusion criteria; intact arches, no missing teeth, and no TMD disorder. The exclusion criteria included students 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. The digital occlusal analysis device used in this study is the OccluSense® (Bausch, Cologne, Germany). Participants were divided into two groups; for group (A) the occlusal contacts was recoded using the osscluSense with customized centering tray, for group (B) the osscluSense was used without the customizable centering tray.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at prosthodontics department Faculty of Dentistry Cairo University

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 26, 2026

Study Start

September 1, 2025

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations