Crossbite (Anterior) (Posterior)NCT04955860
Evaluation of First Molar Inclinations and Transverse Arch Width in Individuals With Posterior Crossbite
An observational study of Crossbite (Anterior) (Posterior) and Dental Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate and compare the inclination of the lower and upper permanent first molars and the transversal width of the lower and upper jaws in individuals of different age groups to evaluate whether the existing anomaly at different ages in individuals with a bilateral posterior crossbite. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Crossbite (Anterior) (Posterior), Dental Malocclusion, Maxillary Anomaly
- What is being tested?
- Dental model analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 1 Jul 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with and without posterior crossbite who applied for orthodontic treatment
Who may be able to join
- For the Working Group;
- Absence of a syndrome or disease affecting the craniofacial and general systemic condition
- Patients who have applied for treatment due to the need for orthodontic treatment
- Adequate radiographic and three-dimensional dental model records before treatment
- Bilateral posterior crossbite
- Absence of anterior crossbite
Show all 13Show fewer
- Absence of loss of lower and upper first permanent molars and eruption of all 4 permanent molars
- For the Control Group;
- Absence of a syndrome or disease affecting the craniofacial and general systemic condition
- Patients who have applied for treatment due to the need for orthodontic treatment
- Adequate radiographic and three-dimensional dental model records before treatment
- Absence of posterior and anterior crossbite
- Absence of loss of lower and upper first permanent molars and eruption of all 4 permanent molars
Who cannot join
- Presence of a syndrome and disease affecting the craniofacial and general systemic condition
- Absence of radiographic and dental model records
- Losing any of the lower or upper permanent first molars
- Presence of anterior crossbite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of First Molar Inclinations and Dental Arch Parameters in Individuals With Bilateral Posterior Crossbite at Different Age Periods
This study aims to evaluate and compare the inclination of the lower and upper permanent first molars and the transversal width of the lower and upper jaws in individuals of different age groups to evaluate whether the existing anomaly at different ages in individuals with a bilateral posterior crossbite. For this reason, first molar tooth inclination and lower and upper jaw transversal width will be evaluated in adolescent and post-adolescent individuals with a bilateral posterior crossbite.
Read the detailed description
The maxillary dental arch covers the mandibular arch in every space like a box cover in normal occlusion. The transversal disappearance of this relationship is called a crossbite. If this deformity occurs between posterior group teeth, it is defined as a posterior crossbite. In other words, in posterior crossbite, while the teeth are in centric occlusion, the vestibule tubercles of the upper posterior teeth come into contact with the central fossa of the lower posterior teeth. This occlusal discrepancy may concern only one tooth, or it may involve multiple teeth or all teeth. A posterior crossbite can be observed unilaterally or bilaterally and is usually caused by insufficient width of the upper jaw compared to the lower jaw.
Crossbite; stated that it is a term used for the abnormal buccal, labial, or lingual relations of the lower and upper jaw teeth or tooth groups when the lower and upper dental arches are in the closing state. Crossbite is divided into two groups as anterior and posterior crossbite according to the region in the mouth. Anterior crossbite indicates malocclusion of the jaws and/or dental arches in the sagittal direction, while posterior crossbite indicates malocclusion in the transversal direction. Posterior crossbite is defined as the contact of the buccal tubercles of the posterior maxillary teeth with the lingual tubercles of the opposite mandibular teeth. This anomaly can be seen unilaterally or bilaterally and may involve one or more teeth. In addition, although the canines were anterior teeth before, these teeth were included in the posterior region while expressing posterior crossbite. A posterior crossbite can be seen in the primary, mixed, and permanent dentition period.
Posteroanterior (PA) cephalograms are the most readily available and reliable diagnostic tool for the radiological identification and evaluation of transversal irregularities. Traditionally, orthodontists have focused on two-dimensional lateral cephalograms; however, treatment is done in all three planes. A planar assessment of the transverse space cannot be made unless the PA cephalogram is analyzed. Typically, standard PA cephalograms were not used as part of routine diagnostic recordings. However, PA radiographs should be added as an additional recording material in individuals with a posterior crossbite.
Digital radiographs and digital photographs are becoming the norm in orthodontic records. Recent developments also include electronic working models. Because the medical and dental anamnesis, digital photos, radiographs, and all treatment notes were in digital format have become desirable to obtain digital study models. Dental cast models have a long and proven history in orthodontics. It has become the "gold standard" in orthodontics with many advantages, from cast models that can be mounted on an articulator for a three-dimensional study, from routine dental examination to ease of manufacture, cheapness, and ease of measurement. Digital operating models offer advantages that include storage and reassessment, ease of cross-transmission, and possibly equal or better diagnostic capabilities. In addition, linear dental anatomical measurements were obtained from plaster and digital models, while Bolton analysis was performed on the cast and digital models.
At the beginning of the treatment, dental plaster models obtained from the lower and upper jaw dimensions will be scanned with a three-dimensional model scanning device (3 Shape R700 3D Scanner, 3 Shape A/S, Copenhagen, Denmark). Scanned models will be analyzed with the 3Shape Orthoanalyzer program (3Shape A/S, Copenhagen, Denmark). A point will be placed on the distal, facial, mesial, and lingual surfaces of each tooth, from the right first permanent molar to the left first permanent molar in the same arch. These points will be chosen by the rules established by Moyers et al. and Brust and McNamara to determine the geometric center of each tooth, the tooth center. This point provides a broader arc width measurement because it will eliminate the effect of tooth rotation. After cast rotation, the first molars' facial and lingual cusp crests will be selected to assess molar tooth tilt and angulation. An inclination below 180 degrees indicates that the molars are inclined buccally, while values above 180 degrees indicate that these teeth are inclined lingually.
Dental arch width measurements will be measured between the following teeth: permanent canines, first premolars, second premolars, and permanent first molars. Arch width will be evaluated with two sets of measurements: the distance from the lingual point of the selected tooth to the similar point on its antimere and between the centroid and antimer of a tooth.
The arch depth shall be measured as the distance from the midpoint between the facial surfaces of the central incisors to the tangent line to the mesial surfaces of the first permanent molars. Arch circumference will be determined by summing the segments between the points of contact from the mesial surface of the first permanent molar to the mesial surface of the opposite first permanent molar.
- Being tested
- Dental model analysis
- Keywords
- posterior crossbite, dental model analysis, molar inclination, dental arch parameter
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental model analysisOther
No interventional treatment intervention will be made for individuals. Digital dental models taken for orthodontic recording will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Individuals with bilateral posterior crossbite will be included. Receives: Other: Dental model analysis | |
| Control Group | Individuals with no anterior and/or posterior crossbite and transversal malocclusion will be included. Receives: Other: Dental model analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular and maxillary first molar positions
The inclinations of the lower and upper permanent first molars in the frontal plane will be evaluated.
Measured: At the beginning of the examination, it will be evaluated as an average of 10 minutes for each patient's lower and upper jaw.
Dimensions of the upper dental arch in the transverse direction
The distances of the right and left permanent canines, first and second premolars, and permanent first molars transversely to each other in the upper jaw of each patient will be evaluated. In addition, dental arch perimeter and dental arch depth will be evaluated.
Measured: At the beginning of the examination, it will be evaluated as an average of 15 minutes for each patient's maxilla.
Dimensions of the lower dental arch in the transverse direction
The distances of the right and left permanent canines, first and second premolars, and permanent first molars transversely to each other in the upper jaw of each patient will be evaluated. In addition, dental arch perimeter and dental arch depth will be evaluated.
Measured: At the beginning of the examination, it will be evaluated as an average of 15 minutes for each patient's mandible.
Evaluation of the transverse dimensions of the lower and upper jaws between different age groups
The differences between the periods of different age groups (12-14 years, 14-16 years and 16-18 years) will also be evaluated separately for each group and parameter.
Measured: At the beginning of the examination, it will be evaluated as an average of 25 minutes for each patient's mandible.
Secondary outcomes (1)
Evaluation of the transverse dimensions of the lower and upper jaws between the sexes
Differences between male and female individuals will also be evaluated separately for each group and parameter.
Measured: At the beginning of the examination, it will be evaluated as an average of 25 minutes for each patient's mandible.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start20 Mar 2020
- Primary completion20 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crossbite (Anterior) (Posterior)Studies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner OZTURK, DDS, MS, TC Erciyes University
- Investigators
- Ahmet Yagci, DDS, PhD, Study director, Erciyes University, Faculty of Dentistry, Department of OrthodonticsSabri I Ramoglu, DDS, PhD, Study chair, Altinbas University, Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955860
- Sponsor's protocol ID
- 2020/44
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical restrictions.
Publications
McNamara JA Jr, Baccetti T, Franchi L, Herberger TA. Rapid maxillary expansion followed by fixed appliances: a long-term evaluation of changes in arch dimensions. Angle Orthod. 2003 Aug;73(4):344-53. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
PubMed 12940553da Silva Filho OG, Ferrari Junior FM, Okada Ozawa T. Dental arch dimensions in Class II division 1 malocclusions with mandibular deficiency. Angle Orthod. 2008 May;78(3):466-74. doi: 10.2319/022307-89.1.
PubMed 18416613McNamara JA Jr. Early intervention in the transverse dimension: is it worth the effort? Am J Orthod Dentofacial Orthop. 2002 Jun;121(6):572-4. doi: 10.1067/mod.2002.124167. No abstract available.
PubMed 12080303
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of First Molar Inclinations and Dental Arch Parameters in Individuals With Bilateral Posterior Crossbite at Different Age Periods
- ClinicalTrials.gov ID
- NCT04955860
- Acronym / sponsor ID
- 2020/44
- Keywords
- posterior crossbite, dental model analysis, molar inclination, dental arch parameter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Jul 2021 (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.
This study aims to evaluate and compare the inclination of the lower and upper permanent first molars and the transversal width of the lower and upper jaws in individuals of different age groups to evaluate whether the existing anomaly at different ages in individuals with a bilateral posterior crossbite. For this reason, first molar tooth inclination and lower and upper jaw transversal width will be evaluated in adolescent and post-adolescent individuals with a bilateral posterior crossbite.
Detailed description
The maxillary dental arch covers the mandibular arch in every space like a box cover in normal occlusion. The transversal disappearance of this relationship is called a crossbite. If this deformity occurs between posterior group teeth, it is defined as a posterior crossbite. In other words, in posterior crossbite, while the teeth are in centric occlusion, the vestibule tubercles of the upper posterior teeth come into contact with the central fossa of the lower posterior teeth. This occlusal discrepancy may concern only one tooth, or it may involve multiple teeth or all teeth. A posterior crossbite can be observed unilaterally or bilaterally and is usually caused by insufficient width of the upper jaw compared to the lower jaw.
Crossbite; stated that it is a term used for the abnormal buccal, labial, or lingual relations of the lower and upper jaw teeth or tooth groups when the lower and upper dental arches are in the closing state. Crossbite is divided into two groups as anterior and posterior crossbite according to the region in the mouth. Anterior crossbite indicates malocclusion of the jaws and/or dental arches in the sagittal direction, while posterior crossbite indicates malocclusion in the transversal direction. Posterior crossbite is defined as the contact of the buccal tubercles of the posterior maxillary teeth with the lingual tubercles of the opposite mandibular teeth. This anomaly can be seen unilaterally or bilaterally and may involve one or more teeth. In addition, although the canines were anterior teeth before, these teeth were included in the posterior region while expressing posterior crossbite. A posterior crossbite can be seen in the primary, mixed, and permanent dentition period.
Posteroanterior (PA) cephalograms are the most readily available and reliable diagnostic tool for the radiological identification and evaluation of transversal irregularities. Traditionally, orthodontists have focused on two-dimensional lateral cephalograms; however, treatment is done in all three planes. A planar assessment of the transverse space cannot be made unless the PA cephalogram is analyzed. Typically, standard PA cephalograms were not used as part of routine diagnostic recordings. However, PA radiographs should be added as an additional recording material in individuals with a posterior crossbite.
Digital radiographs and digital photographs are becoming the norm in orthodontic records. Recent developments also include electronic working models. Because the medical and dental anamnesis, digital photos, radiographs, and all treatment notes were in digital format have become desirable to obtain digital study models. Dental cast models have a long and proven history in orthodontics. It has become the "gold standard" in orthodontics with many advantages, from cast models that can be mounted on an articulator for a three-dimensional study, from routine dental examination to ease of manufacture, cheapness, and ease of measurement. Digital operating models offer advantages that include storage and reassessment, ease of cross-transmission, and possibly equal or better diagnostic capabilities. In addition, linear dental anatomical measurements were obtained from plaster and digital models, while Bolton analysis was performed on the cast and digital models.
At the beginning of the treatment, dental plaster models obtained from the lower and upper jaw dimensions will be scanned with a three-dimensional model scanning device (3 Shape R700 3D Scanner, 3 Shape A/S, Copenhagen, Denmark). Scanned models will be analyzed with the 3Shape Orthoanalyzer program (3Shape A/S, Copenhagen, Denmark). A point will be placed on the distal, facial, mesial, and lingual surfaces of each tooth, from the right first permanent molar to the left first permanent molar in the same arch. These points will be chosen by the rules established by Moyers et al. and Brust and McNamara to determine the geometric center of each tooth, the tooth center. This point provides a broader arc width measurement because it will eliminate the effect of tooth rotation. After cast rotation, the first molars' facial and lingual cusp crests will be selected to assess molar tooth tilt and angulation. An inclination below 180 degrees indicates that the molars are inclined buccally, while values above 180 degrees indicate that these teeth are inclined lingually.
Dental arch width measurements will be measured between the following teeth: permanent canines, first premolars, second premolars, and permanent first molars. Arch width will be evaluated with two sets of measurements: the distance from the lingual point of the selected tooth to the similar point on its antimere and between the centroid and antimer of a tooth.
The arch depth shall be measured as the distance from the midpoint between the facial surfaces of the central incisors to the tangent line to the mesial surfaces of the first permanent molars. Arch circumference will be determined by summing the segments between the points of contact from the mesial surface of the first permanent molar to the mesial surface of the opposite first permanent molar.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Dental model analysisIndividuals with bilateral posterior crossbite will be included. |
| Control Group | – | Other: Dental model analysisIndividuals with no anterior and/or posterior crossbite and transversal malocclusion will be included. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with and without posterior crossbite who applied for orthodontic treatment
Key inclusion criteria (13 listed)
- For the Working Group;
- For the Control Group;
Key exclusion criteria (4 listed)
- Presence of a syndrome and disease affecting the craniofacial and general systemic condition
- Absence of radiographic and dental model records
- Losing any of the lower or upper permanent first molars
- Presence of anterior crossbite
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 |
|---|---|---|
| Dental model analysisNo interventional treatment intervention will be made for individuals. Digital dental models taken for orthodontic recording will be examined. | Other | Control Group, Study Group |
Primary outcome
Mandibular and maxillary first molar positions
Time frame: At the beginning of the examination, it will be evaluated as an average of 10 minutes for each patient's lower and upper jaw.
The inclinations of the lower and upper permanent first molars in the frontal plane will be evaluated.
Dimensions of the upper dental arch in the transverse direction
Time frame: At the beginning of the examination, it will be evaluated as an average of 15 minutes for each patient's maxilla.
The distances of the right and left permanent canines, first and second premolars, and permanent first molars transversely to each other in the upper jaw of each patient will be evaluated. In addition, dental arch perimeter and dental arch depth will be evaluated.
Dimensions of the lower dental arch in the transverse direction
Time frame: At the beginning of the examination, it will be evaluated as an average of 15 minutes for each patient's mandible.
The distances of the right and left permanent canines, first and second premolars, and permanent first molars transversely to each other in the upper jaw of each patient will be evaluated. In addition, dental arch perimeter and dental arch depth will be evaluated.
Evaluation of the transverse dimensions of the lower and upper jaws between different age groups
Time frame: At the beginning of the examination, it will be evaluated as an average of 25 minutes for each patient's mandible.
The differences between the periods of different age groups (12-14 years, 14-16 years and 16-18 years) will also be evaluated separately for each group and parameter.
1 secondary outcome
Evaluation of the transverse dimensions of the lower and upper jaws between the sexes
Time frame: At the beginning of the examination, it will be evaluated as an average of 25 minutes for each patient's mandible.
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 16 Jul 2021.
- Background: PubMed 12940553McNamara JA Jr, Baccetti T, Franchi L, Herberger TA. Rapid maxillary expansion followed by fixed appliances: a long-term evaluation of changes in arch dimensions. Angle Orthod. 2003 Aug;73(4):344-53. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
- Background: PubMed 18416613da Silva Filho OG, Ferrari Junior FM, Okada Ozawa T. Dental arch dimensions in Class II division 1 malocclusions with mandibular deficiency. Angle Orthod. 2008 May;78(3):466-74. doi: 10.2319/022307-89.1.
- Background: PubMed 12080303McNamara JA Jr. Early intervention in the transverse dimension: is it worth the effort? Am J Orthod Dentofacial Orthop. 2002 Jun;121(6):572-4. doi: 10.1067/mod.2002.124167. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical restrictions.
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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.
Ahmet Yagci, DDS, PhD study director
Erciyes University, Faculty of Dentistry, Department of Orthodontics
Sabri I Ramoglu, DDS, PhD study chair
Altinbas University, Faculty of Dentistry, Department of Orthodontics
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 Crossbite (Anterior) (Posterior) and Dental Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 13 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 16 Jul 2021. 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 Turkey (Türkiye). 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?
Mandibular and maxillary first molar positions (time frame: At the beginning of the examination, it will be evaluated as an average of 10 minutes for each patient's lower and upper jaw.). 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 NCT04955860, which also lists 3 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 16 Jul 2021.