NCT04999579

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

11 months

First QC Date

December 31, 2020

Last Update Submit

August 2, 2021

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

  • Occlusal load analysis

    occlusal load analysis of the ultra suction system in complete denture being evaluated by T-scan system

    One year

Study Arms (2)

Complete denture

ACTIVE COMPARATOR

Conventional complete denture without supporting devices

Device: T scan

Ultra suction retained complete denture

EXPERIMENTAL

Conventional complete denture with ultra suction device

Device: T scan

Interventions

T scanDEVICE

Occlusal load analysis

Complete dentureUltra suction retained complete denture

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All implant indicated.

You may not qualify if:

  • All implant contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr university in Cairo

Cairo, Egypt

Location

Study Officials

  • El Naagar

    Badr university in Cairo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 31, 2020

First Posted

August 11, 2021

Study Start

August 15, 2020

Primary Completion

July 20, 2021

Study Completion

August 1, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)