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.
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.
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.
- Conditions
- Class II Malocclusion
- 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 group | Role | What they receive |
|---|---|---|
| Class II Malocclusion | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted4 Dec 2013 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Academy of Interdisciplinary Dental Education and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Sheikh Zayed Federal Postgraduate Medical Institute, University of the Punjab, University College of Medicine and Dentistry, Lahore, Pakistan
- Responsible party
- Principal investigator, Afifa Ehsan, Academy of Interdisciplinary Dental Education and Research
- Investigators
- Ayyaz Ali Khan, Ph. D, Study director, Shaikh Zayed Post Graduate Medical Institute, Lahore, PakistanAfifa Ehsan, B.D.S, Principal investigator, Shaikh Zayed Post Graduate Medical Institute, Lahore, Pakistan
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photographic Analysis Of Soft Tissue Facial Profile In Patients With Class II Malocclusion
- ClinicalTrials.gov ID
- NCT02000557
- Acronym / sponsor ID
- STFP / AIDER-1302-AE
- Conditions
- Class II Malocclusion
- Keywords
- Photographic analysis, Cephalometric analysis, Standardized photographs, Angular measurements, Linear measurements, Malocclusion, Facial Profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Academy of Interdisciplinary Dental Education and ResearchUniversity, hospital or other
- Collaborators
- Sheikh Zayed Federal Postgraduate Medical Institute, University of the Punjab, University College of Medicine and Dentistry, Lahore, Pakistan
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Dec 2013 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Class II Malocclusion | – | – |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Mean values of facial profile angles and linear measurements
Time frame: Within one week after cephalographs and photographs have been taken.
Mean values of soft tissue angles and linear measurements will be determined both on cephalographs and photographs separately.
1 secondary outcome
Comparative angular and linear parameters
Time frame: Within two weeks after cephalographs and photographs have been taken.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- Background: PubMed 17208108Zhang 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.
Related trials for Class II Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
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.
Ayyaz Ali Khan, Ph. D study director
Shaikh Zayed Post Graduate Medical Institute, Lahore, Pakistan
Afifa Ehsan, B.D.S principal investigator
Shaikh Zayed Post Graduate Medical Institute, Lahore, Pakistan
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 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.