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Class II MalocclusionSTFPNCT02000557

Photographic Analysis of Soft Tissue Facial Profile in Patients With Class II Malocclusion

An observational study of Class II Malocclusion, run by Academy of Interdisciplinary Dental Education and Research at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 30 years
Conditions the study is for
Class II Malocclusion
How many people
60 participants
Where
1 sitePakistan
Study dates
Oct 2012to Aug 2013
How long will I take part?
1 Month
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 12 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Shaikh Zayed Medical Complex

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Photographic Analysis Of Soft Tissue Facial Profile In Patients With Class II Malocclusion

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.

Read the detailed description

The goal of orthodontic treatment planning is to achieve facial synchronization by an esthetically pleasing face.It was a common idea in orthodontic treatment planning that soft tissue enhancement would follow the hard tissues, but this did not always happen.The reaction of soft tissue to hard tissue movement is not found to be consistent.With the emergence of a new paradigm in orthodontic diagnosis and treatment planning, greater emphasis has been placed on the relationships of soft tissues and lesser emphasis on the treatment of malocclusion. During the last few years, diagnosis and treatment planning in orthodontics has been reallocated in the direction of facial planning. Formerly, a lot of consideration was placed on the dental and skeletal components but now greater thought is paid to the soft tissue components. The purpose of treatment in the new paradigm is to place the teeth in optimal position with reference to the lips, both vertically as well as antero-posteriorly.

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. Lateral cephalogram has been reported in the literature as an essential element of the diagnostic procedure in orthodontics. Frontal and lateral photographs of the patient correspond to another frequently used diagnostic method. Linear and angular soft tissue facial profile analysis on photographs is carried out corresponding to radiographic cephalometry.

While taking a lateral cephalometric radiograph, the patient is exposed to radiations, moreover; the bony structures overlap each other that enhances the likelihood of misreading of the measured values. 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. It has also been reported that lip-tooth relationships during speech and while smiling are not documented by means of the cephalometric radiograph. Photographs of the face while smiling and at rest are essential to acquire lip-tooth relationships. By means of this, the orthodontist can evaluate anterior tooth as well as adjoining soft tissue relationships. Even though cephalometry is the standard for illustrating skeletal and dental morphology but it might not be appropriate for extensive epidemiologic studies because of the radiations that the patient is exposed to.

Edward Angle, the father of modern orthodontics classified malocclusion based on the position of the maxillary first molar into three types; class I or neutrocclusion, class II or distocclusion and class III or mesiocclusion. Class II malocclusions are contemplated to be one of the most common among all the other forms of malocclusions. It has been reported in the literature that class II malocclusions present an assortment of dental and skeletal configurations. Skeletal class II patterns occur not merely from sagittal discrepancies but as well from vertical discrepancies.

Dental class II is associated with distal relationship of lower teeth with their upper counterparts. It further has two subdivisions, class II division 1 and class II division 2. Class II division 2 malocclusion is less commonly come across as compared to class II division 1. The etiology behind class II malocclusion is multifactorial. An important etiological agent in this type of malocclusion is the soft tissue. For instance, class II division I malocclusion is commonly due to the result of a short or hypotonic upper lip while class II division II is due to the result of bimaxillary retroclination caused by active muscular lips. Prevalence of different occlusions vary with populations of diverse origin and comparable is the case with class II malocclusion. It has been reported in the international literature that class II malocclusion is the most prevalent form of malocclusion as compared to class I and class III malocclusions.

The purpose of the present study is to evaluate the photographic characteristics of soft tissue facial profile of patients with class II malocclusion. The current study has also been planned to observe and compare the results of photographic and cephalometric variables. Soft tissue profile analysis of class II patients would assist us in planning the orthodontic treatment in such individuals. This would serve the purpose of establishing the diagnostic values that would aid the orthodontists in future while planning the treatment plan for class II patients. Planning soft tissue analysis on photographs would also save the patient from excessive radiographic exposure and would help in better planning of the soft tissues.

Keywords
Photographic analysis, Cephalometric analysis, Standardized photographs, Angular measurements, Linear measurements, Malocclusion, Facial Profile
Medical subject headings
Overbite, Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02000557
Study groupRoleWhat they receive
Class II MalocclusionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within one week after cephalographs and photographs have been taken.

Secondary outcomes (1)
  1. Comparative angular and linear parameters

    Mean values of soft tissue angles on cephalographs and photographs will be compared. Similarly comparison of linear measurements on cephalographs and photographs will be performed.

    Measured: Within two weeks after cephalographs and photographs have been taken.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2013
  4. Study completionAug 2013

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT02000557
Sponsor's protocol ID
AIDER-1302-AE
Acronym
STFP
Status last verified
Dec 2013
First submitted
11 Nov 2013
Last updated
5 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17208108

Questions about this trial

What is this clinical trial studying?

An observational study of Class II Malocclusion, run by Academy of Interdisciplinary Dental Education and Research at 1 site in Pakistan.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 5 Dec 2013. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean values of facial profile angles and linear measurements (time frame: Within one week after cephalographs and photographs have been taken.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02000557, which also lists 1 linked publication.

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 5 Dec 2013.

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