- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074370
Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion
March 3, 2017 updated by: Asmaa Ahmed Abo elnaga, Cairo University
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients With Bimaxillary-dentoalveolar Protrusion: A Retrospective Cohort Study
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion.
A Retrospective Cohort Study.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
19
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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Cairo, Egypt
- Asmaa Aboelnaga
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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
14 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Study models of orthodontically treated Egyptian adult female patients with bimaxillary dentoalveolar protrusion .
Description
The selected records should meet the following inclusion criteria:
Pre treatment:
- Full permanent dentition
- No dental nor any craniofacial anomalies
- Molar Class I with bimaxillary-dentoalveolar protrusion
- No excessive over jet or overbite
Treatment mechanics:
- All patients treated with extraction of four 1st premolars
- Retraction of anterior teeth using maximum anchorage mechanics
Post treatment:
- Canine 1 relation
- Molar I relation
Exclusion criteria :
Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gingival display
Time Frame: Change from Baseline gingival display, at an average 24 months
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Amount of maxillary gingival exposure between inferior border of upper lip and marginal gingiva of maxillary central incisors.
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Change from Baseline gingival display, at an average 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral negative space
Time Frame: Change from Baseline lateral negative space, at an average 24 months
|
The buccal corridor between the posterior teeth and the corner of the mouth in smiling.
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Change from Baseline lateral negative space, at an average 24 months
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Smile arc
Time Frame: Change from Baseline smile arc, at an average 24 months
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Relationship between a hypothetical curve drawn along The edges of the maxillary anterior teeth and the inner contour of the lower lip in the posed smile.
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Change from Baseline smile arc, at an average 24 months
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Lip line
Time Frame: Change from Baseline lip line, at an average 24 months
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The height of the upper lip relative to the maxillary central incisors.
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Change from Baseline lip line, at an average 24 months
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Smile width
Time Frame: Change from Baseline smile width, at an average 24 months
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The distance between the most medial points on the lips at the angles of the mouth (Left to right cheilion, CHR to CHL).
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Change from Baseline smile width, at an average 24 months
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Smile height
Time Frame: Change from Baseline smile height, at an average 24 months
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Distance from the most inferior point on the upper lip between the maxillary central inciors to the most superior point on the lower lip on a perpendicular vertical line from the upper point (upper stomion to lower stomion,UST to LST).
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Change from Baseline smile height, at an average 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
April 1, 2017
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
February 25, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (Actual)
March 8, 2017
Study Record Updates
Last Update Posted (Actual)
March 8, 2017
Last Update Submitted That Met QC Criteria
March 3, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CEBC-CU-2017-02-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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