NCT04955860

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
Last Updated

July 16, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 5, 2021

Last Update Submit

July 10, 2021

Conditions

Keywords

posterior crossbitedental model analysismolar inclinationdental arch parameter

Outcome Measures

Primary Outcomes (4)

  • Mandibular and maxillary first molar positions

    The inclinations of the lower and upper permanent first molars in the frontal plane will be evaluated.

    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.

    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.

    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.

    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

    At the beginning of the examination, it will be evaluated as an average of 25 minutes for each patient's mandible.

Study Arms (2)

Study Group

Individuals with bilateral posterior crossbite will be included.

Other: Dental model analysis

Control Group

Individuals with no anterior and/or posterior crossbite and transversal malocclusion will be included.

Other: Dental model analysis

Interventions

No interventional treatment intervention will be made for individuals. Digital dental models taken for orthodontic recording will be examined.

Control GroupStudy Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsDifferences between male and female individuals will also be evaluated separately for each group and parameter.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Individuals with and without posterior crossbite who applied for orthodontic treatment

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 12940553BACKGROUND
  • 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.

    PMID: 18416613BACKGROUND
  • 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.

    PMID: 12080303BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Data of cast plaster model scans of the lower and upper jaws obtained from individuals for routine treatment procedures were obtained and stored digitally.

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Ahmet Yagci, DDS, PhD

    Erciyes University, Faculty of Dentistry, Department of Orthodontics

    STUDY DIRECTOR
  • Sabri I Ramoglu, DDS, PhD

    Altinbas University, Faculty of Dentistry, Department of Orthodontics

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 9, 2021

Study Start

March 20, 2020

Primary Completion

March 20, 2021

Study Completion

July 1, 2021

Last Updated

July 16, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical restrictions.

Locations