NCT03074370

Brief Summary

Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion. A Retrospective Cohort Study.

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
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 8, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 25, 2017

Last Update Submit

March 3, 2017

Conditions

Bimaxillary Protrusion

Outcome Measures

Primary Outcomes (1)

  • Gingival display

    Amount of maxillary gingival exposure between inferior border of upper lip and marginal gingiva of maxillary central incisors.

    Change from Baseline gingival display, at an average 24 months

Secondary Outcomes (5)

  • Lateral negative space

    Change from Baseline lateral negative space, at an average 24 months

  • Smile arc

    Change from Baseline smile arc, at an average 24 months

  • Lip line

    Change from Baseline lip line, at an average 24 months

  • Smile width

    Change from Baseline smile width, at an average 24 months

  • Smile height

    Change from Baseline smile height, at an average 24 months

Eligibility Criteria

Age14 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult Egyptian females with bimaxillary-dentoalveolar protrusion.
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Study models of orthodontically treated Egyptian adult female patients with bimaxillary dentoalveolar protrusion .

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asmaa Aboelnaga

Cairo, Egypt

Location

Central Study Contacts

fady hussein fahim, phd

CONTACT

+201006882595fady.hussein@dentistry.cu.edu.eg

asmaa aboelnaga, master

CONTACT

+201111667881dr.a.aboelnaga@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2017

First Posted

March 8, 2017

Study Start

April 1, 2017

Primary Completion

February 1, 2018

Study Completion

March 1, 2018

Last Updated

March 8, 2017

Record last verified: 2017-03

Locations

EG(1)