MalocclusionNCT03648515
Evaluation of the Accuracy of Measurements Made on Images Taken From the Mouth for Dental Arches
An observational study of Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
The general trend in the orthodontic practice is to become digital in many aspects. Since 1980s, digital photographs have been available and they play a principal role in the orthodontic practice for documentation and diagnosis purposes. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Plaster models, Digital Images of the dental arches and Digital images of models
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 15 Jun 2018to 15 Sep 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with different levels of malocclusion
Who may be able to join
- Complete permanent dentition
- Absence of any big carious lesions
- Absence of fixed prosthodontics (fixed bridges)
- Absence of shape and size disturbances (regardless third molar)
- Presence of upper and lower crowded arches
Who cannot join
- Missing teeth
- Migrated teeth
- Impacted teeth
- Severely broken down teeth or big carious lesions
- Presence of fixed prosthodontics (fixed bridges)
- Presence of shape and size disturbances
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus, DM20AM18
About this study
Official title: Evaluation of the Validity and Reliability of Measurements Made on Intra-oral Images of the Dental Arches Compared to Those Made on Poured Plaster Models in the Assessment of Tooth-size-arch-length-discrepancy, Bolton's Analysis and Little's Index of Irregularity.
The general trend in the orthodontic practice is to become digital in many aspects. Since 1980s, digital photographs have been available and they play a principal role in the orthodontic practice for documentation and diagnosis purposes. Now photographs have an important role in teaching, scientific research and medical examination.
Successful orthodontic treatment is based on a comprehensive diagnosis and treatment planning. A few of the fundamental factors in the diagnosis are the spacing condition, tooth size, arch form and dimensions, as well as the tooth-arch discrepancies. Intraoral photographs' major role is to enable orthodontists to document and analyze the occlusal relationships as well as the dental and soft-tissue features in order to arrive at a good diagnosis and an appropriate treatment plan.
Read more
In 1975, Robert Little developed Little's irregularity index (LII). The index was proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements was the LII score. The higher the index value, the more severe irregularity of the teeth was. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity
Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone. Bolton analysis is another important measurement used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formulas, the overall ratio should be 91.3% (±1.91) and the partial (anterior) ratio should be 77.2% (±1.65).
The validity and reliability of performing the above mentioned analyses on images taken of the dental arches have not been evaluated yet in the literature. This is the aim of the current project.
Read the detailed description
Assessment of the LII scores, TSALD, Bolton analysis has been performed by the majority of previous studies using plaster models and calipers in a direct manner. Others have measured previous variables indirectly using 2-dimensional and 3-dimensional (3D) methods. 2D methods have included 2D scans of plaster models or 2D images of the occlusal views. The obtained images have been then analyzed either manually or on-screen using dedicated software. 3D methods have included digital models and have been used by several researchers. Although the wealth of knowledge 3D methods provide, they require the use of 3D imaging techniques with the resultant additional costs, time and labor.
Many studies have used 2D digital images of poured plaster models to perform software-based measurements of tooth movement during active treatment but these studies have not reported the accuracy and reproducibility of their methods. Dental impressions have been required to obtain proper study models. This procedure is a time- and labor-consuming for the orthodontist and could be exhausting to the patient. When braces are fitted, impression taking becomes a difficult task and if several impressions are required in the context of a research project, this would impose additional burden to patients and researchers. Therefore, taking intra-oral images of dental arches instead of impressions seems to be a very convenient alternative.
Validity and reliability of measurements made on photographs of study models have been evaluated in previous reports. However, it seems to be that there is only one paper in the literature with the aim of validating the use of intra-oral images of the dental arches for performing dental measurement. They found that the analysis of LII was valid. However, the practicability of their suggested method of imaging was questionable and their evaluation was only confined to the LII, which is not the only variable that is used in our ordinary plaster model analysis.
Therefore, the primary aim of the current work were to evaluate the validity and reliability of measurements made directly on intraoral photographs compared to those made on poured plaster models in the assessment of the LII, TSALD, and Bolton ratios. As a secondary aim, the comparisons were also accomplished with those measurements made on photographs taken of the corresponding poured plaster models .
- Conditions
- Malocclusion
- Being tested
- Plaster models, Digital Images of the dental arches, Digital images of models
- Keywords
- Validity, Reliability, Reproducibility, Intra-oral images, Plaster models, Digital images, Little's index of irregularity, Bolton's analysis, Tooth-size-arch-length-discrepancy
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster modelsDiagnostic test
Also called Study models, Study casts, Poured study models
The impressions taken of the dental arches will be poured with hard gypsum in order to make use of the models for taking measurements. These measurements will be considered the gold standard.
Digital Images of the dental archesDiagnostic test
Also called Intra-oral images
The dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes.
Digital images of modelsDiagnostic test
The poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Malocclusion patients | Patients with different types of malocclusion will be included. Plaster models will be fabricated after pouring the impressions with hard gypsum.
Then, digital images of the dental arches of each patient will be taken using a dedicated camera with very high resolution. Finally, digital images of models that were poured with gypsum will be taken also with the same camera and in the same conditions. Receives: Diagnostic Test: Plaster models; Diagnostic Test: Digital Images of the dental arches; Diagnostic Test: Digital images of models |
What is being measured
The primary outcome is the main question the study is designed to answer.
Little's Index of Irregularity (LII)
Robert Little developed Little's irregularity index (LII) in 1975. The index has been proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements is considered the LII score. The higher the index value, the more severe irregularity of the teeth is. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity.
Measured: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Partial Bolton's Ratio
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65)
The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Measured: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Overall Bolton's Ratio
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%.
The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Measured: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Tooth-size-arch-length-discrepancy (TSALD)
Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone.
The formula is The sum of mesio-distal widths of all permanent teeth (mesial to the first lower/upper molars) minus the sum of the basal bone length (measured by a specific thread). The result is expressed in mm.
Measured: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start15 Jun 2018
- Primary completion19 Aug 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wael Al-Rasheed Omer, DDS, Principal investigator, MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, SyriaAmer M Owayda, DDS, Principal investigator, MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIAMohammad Y Hajeer, DDS MSc PhD, Study director, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, SYRIARashad Murad, DDS MSc PhD, Study director, Associate Professor of Toxicology, University of Damascus Pharmacological College, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648515
- Sponsor's protocol ID
- UDDS-Ortho-11-2018
- Status last verified
- Jul 2019
- First submitted
- 24 Aug 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almasoud N, Bearn D. Little's irregularity index: photographic assessment vs study model assessment. Am J Orthod Dentofacial Orthop. 2010 Dec;138(6):787-94. doi: 10.1016/j.ajodo.2009.01.031.
PubMed 21130338Jones ML. The Barry Project--a three-dimensional assessment of occlusal treatment change in a consecutively referred sample: the incisors. Br J Orthod. 1990 Feb;17(1):1-19. doi: 10.1179/bjo.17.1.1.
PubMed 2310735Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
PubMed 1059332Puneky PJ, Sadowsky C, BeGole EA. Tooth morphology and lower incisor alignment many years after orthodontic therapy. Am J Orthod. 1984 Oct;86(4):299-305. doi: 10.1016/0002-9416(84)90140-4.
PubMed 6592978Surbeck BT, Artun J, Hawkins NR, Leroux B. Associations between initial, posttreatment, and postretention alignment of maxillary anterior teeth. Am J Orthod Dentofacial Orthop. 1998 Feb;113(2):186-95. doi: 10.1016/s0889-5406(98)70291-4.
PubMed 9484210Tran AM, Rugh JD, Chacon JA, Hatch JP. Reliability and validity of a computer-based Little irregularity index. Am J Orthod Dentofacial Orthop. 2003 Mar;123(3):349-51. doi: 10.1067/mod.2003.76. No abstract available.
PubMed 12637908West AE, Jones ML, Newcombe RG. Multiflex versus superelastic: a randomized clinical trial of the tooth alignment ability of initial arch wires. Am J Orthod Dentofacial Orthop. 1995 Nov;108(5):464-71. doi: 10.1016/s0889-5406(95)70046-3.
PubMed 7484965
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity and Reliability of Measurements Made on Intra-oral Images of the Dental Arches Compared to Those Made on Poured Plaster Models in the Assessment of Tooth-size-arch-length-discrepancy, Bolton's Analysis and Little's Index of Irregularity.
- ClinicalTrials.gov ID
- NCT03648515
- Acronym / sponsor ID
- UDDS-Ortho-11-2018
- Conditions
- Malocclusion
- Keywords
- Validity, Reliability, Reproducibility, Intra-oral images, Plaster models, Digital images, Little's index of irregularity, Bolton's analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 27 Aug 2018 (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.
The general trend in the orthodontic practice is to become digital in many aspects. Since 1980s, digital photographs have been available and they play a principal role in the orthodontic practice for documentation and diagnosis purposes. Now photographs have an important role in teaching, scientific research and medical examination.
Successful orthodontic treatment is based on a comprehensive diagnosis and treatment planning. A few of the fundamental factors in the diagnosis are the spacing condition, tooth size, arch form and dimensions, as well as the tooth-arch discrepancies. Intraoral photographs' major role is to enable orthodontists to document and analyze the occlusal relationships as well as the dental and soft-tissue features in order to arrive at a good diagnosis and an appropriate treatment plan.
In 1975, Robert Little developed Little's irregularity index (LII). The index was proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements was the LII score. The higher the index value, the more severe irregularity of the teeth was. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity
Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone. Bolton analysis is another important measurement used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formulas, the overall ratio should be 91.3% (±1.91) and the partial (anterior) ratio should be 77.2% (±1.65).
The validity and reliability of performing the above mentioned analyses on images taken of the dental arches have not been evaluated yet in the literature. This is the aim of the current project.
Detailed description
Assessment of the LII scores, TSALD, Bolton analysis has been performed by the majority of previous studies using plaster models and calipers in a direct manner. Others have measured previous variables indirectly using 2-dimensional and 3-dimensional (3D) methods. 2D methods have included 2D scans of plaster models or 2D images of the occlusal views. The obtained images have been then analyzed either manually or on-screen using dedicated software. 3D methods have included digital models and have been used by several researchers. Although the wealth of knowledge 3D methods provide, they require the use of 3D imaging techniques with the resultant additional costs, time and labor.
Many studies have used 2D digital images of poured plaster models to perform software-based measurements of tooth movement during active treatment but these studies have not reported the accuracy and reproducibility of their methods. Dental impressions have been required to obtain proper study models. This procedure is a time- and labor-consuming for the orthodontist and could be exhausting to the patient. When braces are fitted, impression taking becomes a difficult task and if several impressions are required in the context of a research project, this would impose additional burden to patients and researchers. Therefore, taking intra-oral images of dental arches instead of impressions seems to be a very convenient alternative.
Validity and reliability of measurements made on photographs of study models have been evaluated in previous reports. However, it seems to be that there is only one paper in the literature with the aim of validating the use of intra-oral images of the dental arches for performing dental measurement. They found that the analysis of LII was valid. However, the practicability of their suggested method of imaging was questionable and their evaluation was only confined to the LII, which is not the only variable that is used in our ordinary plaster model analysis.
Therefore, the primary aim of the current work were to evaluate the validity and reliability of measurements made directly on intraoral photographs compared to those made on poured plaster models in the assessment of the LII, TSALD, and Bolton ratios. As a secondary aim, the comparisons were also accomplished with those measurements made on photographs taken of the corresponding poured plaster models .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malocclusion patients | – | Diagnostic Test: Plaster models, Diagnostic Test: Digital Images of the dental arches, Diagnostic Test: Digital images of modelsPatients with different types of malocclusion will be included. Plaster models will be fabricated after pouring the impressions with hard gypsum. Then, digital images of the dental arches of each patient will be taken using a dedicated camera with very high resolution. Finally, digital images of models that were poured with gypsum will be taken also with the same camera and in the same conditions. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with different levels of malocclusion
Key inclusion criteria (5 listed)
- Complete permanent dentition
- Absence of any big carious lesions
- Absence of fixed prosthodontics (fixed bridges)
- Absence of shape and size disturbances (regardless third molar)
- Presence of upper and lower crowded arches
Key exclusion criteria (6 listed)
- Missing teeth
- Migrated teeth
- Impacted teeth
- Severely broken down teeth or big carious lesions
- Presence of fixed prosthodontics (fixed bridges)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaster modelsAlso: Study models, Study casts, Poured study modelsThe impressions taken of the dental arches will be poured with hard gypsum in order to make use of the models for taking measurements. These measurements will be considered the gold standard. | Diagnostic test | Malocclusion patients |
| Digital Images of the dental archesAlso: Intra-oral imagesThe dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes. | Diagnostic test | Malocclusion patients |
| Digital images of modelsThe poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes. | Diagnostic test | Malocclusion patients |
Primary outcome
Little's Index of Irregularity (LII)
Time frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Robert Little developed Little's irregularity index (LII) in 1975. The index has been proposed to assess teeth irregularity, crowding, relapse, and alignment of anterior teeth as it measured the linear displacements in the horizontal plane between contact points of anterior teeth, ignoring vertical displacement, from mesial surface of one canine to the contra-lateral one. The sum of the 5 liner measurements of displacements is considered the LII score. The higher the index value, the more severe irregularity of the teeth is. LII has been originally developed for mandibular incisors to study relapse; however, researchers have used it to assess upper and lower incisors irregularity.
Partial Bolton's Ratio
Time frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the partial ratio should be 77.2% (±1.65) The formula is the sum of the mesio-distal widths of the lower six anterior teeth divided by the sum of the mesio-distal widths of the upper six anterior teeth.
Overall Bolton's Ratio
Time frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Bolton analysis is used to identify disharmony between maxillary and mandibular tooth size which is considered an important factor to ensure the success of orthodontic treatment. With the application of the suggested formula, the overall ratio should be 91.3%. The formula is the sum of the mesio-distal widths of the lower twelve teeth divided by the sum of the mesio-distal widths of the upper twelve teeth.
Tooth-size-arch-length-discrepancy (TSALD)
Time frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.
Tooth-size-arch-length discrepancy (TSALD) is widely used on study models to assess the level of harmony between tooth size and the supporting basal bone. The formula is The sum of mesio-distal widths of all permanent teeth (mesial to the first lower/upper molars) minus the sum of the basal bone length (measured by a specific thread). The result is expressed in mm.
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 18 Jul 2019.
- Background: PubMed 21130338Almasoud N, Bearn D. Little's irregularity index: photographic assessment vs study model assessment. Am J Orthod Dentofacial Orthop. 2010 Dec;138(6):787-94. doi: 10.1016/j.ajodo.2009.01.031.
- Background: PubMed 2310735Jones ML. The Barry Project--a three-dimensional assessment of occlusal treatment change in a consecutively referred sample: the incisors. Br J Orthod. 1990 Feb;17(1):1-19. doi: 10.1179/bjo.17.1.1.
- Background: PubMed 1059332Little RM. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod. 1975 Nov;68(5):554-63. doi: 10.1016/0002-9416(75)90086-x.
- Background: PubMed 6592978Puneky PJ, Sadowsky C, BeGole EA. Tooth morphology and lower incisor alignment many years after orthodontic therapy. Am J Orthod. 1984 Oct;86(4):299-305. doi: 10.1016/0002-9416(84)90140-4.
- Background: PubMed 9484210Surbeck BT, Artun J, Hawkins NR, Leroux B. Associations between initial, posttreatment, and postretention alignment of maxillary anterior teeth. Am J Orthod Dentofacial Orthop. 1998 Feb;113(2):186-95. doi: 10.1016/s0889-5406(98)70291-4.
- Background: PubMed 12637908Tran AM, Rugh JD, Chacon JA, Hatch JP. Reliability and validity of a computer-based Little irregularity index. Am J Orthod Dentofacial Orthop. 2003 Mar;123(3):349-51. doi: 10.1067/mod.2003.76. No abstract available.
- Background: PubMed 7484965West AE, Jones ML, Newcombe RG. Multiflex versus superelastic: a randomized clinical trial of the tooth alignment ability of initial arch wires. Am J Orthod Dentofacial Orthop. 1995 Nov;108(5):464-71. doi: 10.1016/s0889-5406(95)70046-3.
- Individual participant dataSharing planned: No
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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.
Wael Al-Rasheed Omer, DDS principal investigator
MSc student at the Orthodontic Department, University of Damascus Dental School, Damascus, Syria
Amer M Owayda, DDS principal investigator
MSc student in Orthodontics, University of Damascus Dental School, Damascus, SYRIA
Mohammad Y Hajeer, DDS MSc PhD study director
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, SYRIA
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 Malocclusion, run by Damascus University at 1 site in Syria.
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 5 inclusion and 6 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 18 Jul 2019. 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 Syria. 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?
Little's Index of Irregularity (LII) (time frame: After seven days of taking the impressions of the dental arches. Impressions will be taken in the same day of patient's entry to the cohort.). The study lists 4 primary outcomes in all. 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 NCT03648515, which also lists 7 linked publications.
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 18 Jul 2019.