- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03360513
Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
August 9, 2023 updated by: Mario Cappellette Jr , PhD,DDS, Federal University of São Paulo
This study aims to determine the shape and dimension of dental arches from a lingual perspective, and determine shape and size used for lingual Orthodontics.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys.
Maxillary and mandibular dental casts were digitized (3D) and the images were analyzed by Delcam Power SHAPET 2010 software.
Landmarks on the lingual surface of teeth were selected to determine the shape and size of dental arches.
Study Type
Observational
Enrollment (Actual)
70
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
-
-
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São Paulo, Brazil, 04020041
- Disciplina de Otorrinolaringologia Pediatrica
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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
15 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years
Description
Inclusion Criteria:criterion was that individuals should be at least 15 years of age all permanent teeth in occlusion -
Exclusion Criteria:with no odontogenic abnormalities
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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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
general group
Comprised 70 caucasian Brazilian individuals with normal occlusion and at least four of Andrew's six keys.
|
The sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion.
14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship).
Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Statistic study
Time Frame: six months
|
describe arch form similar a mushroom arch
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shirley SN Pignatari, PHD, Federal University of São Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 1, 2016
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
March 30, 2019
Study Registration Dates
First Submitted
November 28, 2017
First Submitted That Met QC Criteria
November 28, 2017
First Posted (Actual)
December 4, 2017
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- FUSãoPaulo15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The 70 pairs of cast models were digitized with a 3D Dental Wings™ Scanner (model DW5-140, Montreal, Quebec, Canada).
Images were analyzed by Delcam Power SHAPE™ software (2010, Birmingham, UK).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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