NCT02000557

Brief Summary

The present day social setup considers facial charisma as an important physical characteristic. The facial characteristics of an individual are measured through anthropometry, photogrammetry, computer imaging and cephalometric radiographs. Cephalometric radiographs offer significant diagnostic information regarding the association between the dental and skeletal structures. By means of photogrammetric measurements, a fresh diagnostic resource is accessible to the orthodontist which permits an intangible, radiation free attainment of measure points of soft tissue with no instrumental expense and radiation to the patient. Orthodontic patients range from adolescents to senior citizens and originate from an assortment of populations, thus an extensive series of representative norms will be ideal. Knowledge of the normal dentofacial outline of every group will make certain better success of treatment to set up the best possible facial agreement. Hence, it is extremely important to assess the soft tissue profile of a patient as it is one of the most vital components of orthodontic diagnosis and treatment planning. The purpose of the present study is to evaluate the photographic characteristics of soft tissue facial profile of patients with class II malocclusion as ethnic differences have been found to be reported in the literature. It is hypothesized that soft tissue facial characteristics on lateral profile photographs and lateral cephalometric radiographs in a sample of local population with class II malocclusion are closely related.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
Last Updated

December 5, 2013

Status Verified

December 1, 2013

Enrollment Period

9 months

First QC Date

November 11, 2013

Last Update Submit

December 4, 2013

Conditions

Keywords

Photographic analysisCephalometric analysisStandardized photographsAngular measurementsLinear measurementsMalocclusionFacial Profile

Outcome Measures

Primary Outcomes (1)

  • Mean values of facial profile angles and linear measurements

    Mean values of soft tissue angles and linear measurements will be determined both on cephalographs and photographs separately.

    Within one week after cephalographs and photographs have been taken.

Secondary Outcomes (1)

  • Comparative angular and linear parameters

    Within two weeks after cephalographs and photographs have been taken.

Study Arms (1)

Class II Malocclusion

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study population comprises of subjects reporting to Dental department of Shaikh Zayed Medical Complex, Lahore and Department of Orthodontics at University College of Medicine and Dentistry, Lahore.

You may qualify if:

  • Orthodontic patients whose cephalometric radiographs have already been done.
  • Males and females in the age group of 12 - 30 years.
  • Subjects with convex profiles.
  • Intact set of permanent dentition upto the second molars.

You may not qualify if:

  • Subjects who have previously received orthodontic treatment and orthognathic surgery.
  • Subjects with Temporomandibular joint disorder, cleft lip and palate, any kind of syndrome and traumatic deformity.
  • Subjects with extractions other than third molars.
  • Male subjects with beards.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Medical Complex

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Zhang X, Hans MG, Graham G, Kirchner HL, Redline S. Correlations between cephalometric and facial photographic measurements of craniofacial form. Am J Orthod Dentofacial Orthop. 2007 Jan;131(1):67-71. doi: 10.1016/j.ajodo.2005.02.033.

    PMID: 17208108BACKGROUND

MeSH Terms

Conditions

OverbiteMalocclusion

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IITooth DiseasesStomatognathic Diseases

Study Officials

  • Ayyaz Ali Khan, Ph. D

    Shaikh Zayed Post Graduate Medical Institute, Lahore, Pakistan

    STUDY DIRECTOR
  • Afifa Ehsan, B.D.S

    Shaikh Zayed Post Graduate Medical Institute, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Afifa Ehsan

Study Record Dates

First Submitted

November 11, 2013

First Posted

December 4, 2013

Study Start

October 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

December 5, 2013

Record last verified: 2013-12

Locations