NCT03714932

Brief Summary

Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation:

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

September 3, 2020

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 1, 2018

Last Update Submit

September 2, 2020

Conditions

Dental Malocclusion

Keywords

Arch analysis, Mixed dentition,Tanaka & Johnston

Outcome Measures

Primary Outcomes (1)

  • accuracy of digital models in arch analysis.

    using digital models through software(3shape ortho analyzer) to evaluate it's accuracy in arch analysis through prediction equation(Tanaka and Johnston equations)versus plaster models by using manual caliper.

    6 months

Interventions

3shape ortho analyzer softwareDIAGNOSTIC_TEST

Arch analysis , manual analysis , digital analysis , Mixed dentition , Tanaka and Johnston

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged six to Ten years.

You may qualify if:

  • Aged range from 6-10.
  • patients medically free from any syndromes that could affect the normal eruption.
  • Normal radiographical findings in teeth eruption.
  • Erupted lower incisors.

You may not qualify if:

  • Extracted lower 1st permanent molar.
  • congenital missing of incisors.
  • Badly decayed permanent incisors or 1st molar that could compromise the measurements.
  • Any sensitivity to any of the impression materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sara Mohamed

Cairo, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • sara Mohamed Tag El Deen, Master

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

sara Mohamed Tag El Deen, master

CONTACT

01066960533sara-mohamed@dentistry.cu.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student in Cairo university (principle Invistigator)

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 22, 2018

Study Start

October 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 20, 2020

Last Updated

September 3, 2020

Record last verified: 2019-10

Locations

EG(1)