Bimaxillary ProtrusionNCT03074370
Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion
An observational study of Bimaxillary Protrusion, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion. A Retrospective Cohort Study. Read more about this study
- Who is it for?
- Ages 14 to 24 years, women only
- Conditions the study is for
- Bimaxillary Protrusion
- How many people
- 19 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- Women only
- Child, Adult
Study population: Study models of orthodontically treated Egyptian adult female patients with bimaxillary dentoalveolar protrusion .
Who may be able to join
None listed.
Who cannot join
- Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bimaxillary Protrusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival display
Amount of maxillary gingival exposure between inferior border of upper lip and marginal gingiva of maxillary central incisors.
Measured: Change from Baseline gingival display, at an average 24 months
Secondary outcomes (5)
Lateral negative space
The buccal corridor between the posterior teeth and the corner of the mouth in smiling.
Measured: Change from Baseline lateral negative space, at an average 24 months
Smile arc
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.
Measured: Change from Baseline smile arc, at an average 24 months
Lip line
The height of the upper lip relative to the maxillary central incisors.
Measured: Change from Baseline lip line, at an average 24 months
Smile width
The distance between the most medial points on the lips at the angles of the mouth (Left to right cheilion, CHR to CHL).
Measured: Change from Baseline smile width, at an average 24 months
Smile height
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).
Measured: Change from Baseline smile height, at an average 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Apr 2017 (estimated)
- Primary completion1 Feb 2018 (estimated)
- Study completion1 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProtrusionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ahmed Abo elnaga, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074370
- Sponsor's protocol ID
- CEBC-CU-2017-02-08
- Status last verified
- Mar 2017
- First submitted
- 25 Feb 2017
- Last updated
- 8 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients With Bimaxillary-dentoalveolar Protrusion: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT03074370
- Acronym / sponsor ID
- CEBC-CU-2017-02-08
- Conditions
- Bimaxillary Protrusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (estimated)
- Primary completion
- 1 Feb 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion.
A Retrospective Cohort Study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 24 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Study models of orthodontically treated Egyptian adult female patients with bimaxillary dentoalveolar protrusion .
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gingival display
Time frame: Change from Baseline gingival display, at an average 24 months
Amount of maxillary gingival exposure between inferior border of upper lip and marginal gingiva of maxillary central incisors.
5 secondary outcomes
Lateral negative space
Time frame: Change from Baseline lateral negative space, at an average 24 months
Smile arc
Time frame: Change from Baseline smile arc, at an average 24 months
Lip line
Time frame: Change from Baseline lip line, at an average 24 months
Smile width
Time frame: Change from Baseline smile width, at an average 24 months
Smile height
Time frame: Change from Baseline smile height, at an average 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bimaxillary Protrusion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fady hussein fahim, phd (+201006882595, fady.hussein@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival display (time frame: Change from Baseline gingival display, at an average 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.