NCT07037407

Brief Summary

In vivo prospective clinical study will be designed, 12 participants will be included. After intraoral scanning, a conventional impression is made for each patient. The groups will be compared for accuracy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

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

October 18, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 12, 2025

Last Update Submit

June 21, 2025

Conditions

Keywords

Flabby ridgeIOS

Outcome Measures

Primary Outcomes (1)

  • accuracy evaluation

    Accuracy Evaluation: The accuracy of the digital impressions versus conventional impression based on trueness and precision will be evaluated. \- Trueness: Trueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files. Precision: Precision is a statistical measure that quantifies the level of similarity between repeated samples within the same group. In the context of this study, the IOS impression STL files will be compared to each other in a manner similar to the previous comparisons

    1 month

Study Arms (2)

WTI

ACTIVE COMPARATOR

Control: Window technique for Maxillary flabby ridge using two consistencies of PVS impression material then poured to obtain a stone model which will be scanned using a laboratory extra oral scan to convert it into an STL file (WTI)

Procedure: WTI

IOS

EXPERIMENTAL

intra oral scanning of flabby ridge

Procedure: IOS

Interventions

IOSPROCEDURE

Intra oral scanning

IOS
WTIPROCEDURE

window technique Impression

WTI

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October University for Modern Sciences and Arts

Giza, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof Of Prosthodontics

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 25, 2025

Study Start

October 18, 2024

Primary Completion

March 24, 2025

Study Completion

April 24, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations