NCT06146153

Brief Summary

the aim of this study is to compare the influence of different palatal vault configurations on the accuracy and scan speed of IO scans in cases of completely edentulous arches. The null hypothesis is that there is no difference in scanning time, and trueness and precision of IO scans between class I, II and III palatal vault configurations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

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

November 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

November 18, 2023

Last Update Submit

April 1, 2024

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • 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

    15 days

Secondary Outcomes (1)

  • precision

    15 days

Study Arms (3)

Class I

(medium U-vault)

Diagnostic Test: digital impression

Class II

(deep-vault)

Diagnostic Test: digital impression

Class III

flat vault

Diagnostic Test: digital impression

Interventions

digital impressionDIAGNOSTIC_TEST

intra oral scanning

Class IClass IIClass III

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible participants who will comprehend the study's purpose and expresse their willingness to take part and sign a consent form will be enrolled in the study. The subjects will consist of dental patients who were seeking treatment for complete tooth loss in either the upper or lower jaw, or both. A total of thirty patients with complete edentulism, attending the outpatient clinic of MSA University, will be recruited for this research.

You may qualify if:

  • \. Full tooth loss in the maxilla; 2. Absence of infectious diseases; 3. Systemic good health; 4. Age between 50 and 75 years; 5. Willingness to cooperate throughout the data collection process

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MSA University

Giza, 12451, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Dina Elawady, A.Prof

    MSA University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

November 18, 2023

First Posted

November 24, 2023

Study Start

November 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 15, 2024

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)