Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

August 2, 2021 updated by: Shady El Naggar, Badr University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

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

  • Egypt
      • Cairo, Egypt
        • Badr University in Cairo

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All implant indicated.

Exclusion Criteria:

  • All implant contraindicated

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete denture
Conventional complete denture without supporting devices
Device: T scan
Occlusal load analysis
Experimental: Ultra suction retained complete denture
Conventional complete denture with ultra suction device
Device: T scan
Occlusal load analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal load analysis
Time Frame: One year
occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Badr University

Investigators

  • Principal Investigator: El Naagar, Badr University in Cairo

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)

August 15, 2020

Primary Completion (Actual)

July 20, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

December 31, 2020

First Submitted That Met QC Criteria

August 2, 2021

First Posted (Actual)

August 11, 2021

Study Record Updates

Last Update Posted (Actual)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1122110085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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