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NCT04999579 Clinical Trial

Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

Complete Edentulism Clinical Trial

Official title:
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04999579
Other study ID # 1122110085
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2020
Est. completion date August 1, 2021

Study information
Verified date August 2021
Source Badr University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.

Description:

Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed. The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements. The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004", 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 1, 2021
Est. primary completion date July 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All implant indicated. Exclusion Criteria: - All implant contraindicated

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T scan
Occlusal load analysis

Locations
Country Name City State
Egypt Badr university in Cairo Cairo

Sponsors (1)
Lead Sponsor Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occlusal load analysis occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system One year
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