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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).

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

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
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
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  • 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.

Turkey (Türkiye)1 site
  • Erciyes University

    Kayseri, 38039

Other trials in Turkey (Türkiye)

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 groups in NCT04955860
Study groupRoleWhat they receive
Study GroupIndividuals with bilateral posterior crossbite will be included.
Receives: Other: Dental model analysis
Control GroupIndividuals 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.

  1. 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.

  2. 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.

  3. 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.

  4. 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)
  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.

  1. First posted9 Jul 2021
  2. Study start20 Mar 2020
  3. Primary completion20 Mar 2021
  4. Study completion1 Jul 2021

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
Cohort
Time perspective
Retrospective
Enrolment
120 participants (actual)
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 12940553
  • da 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 18416613
  • McNamara 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

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.

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