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OpenTrials
Completed

NCT Number: NCT04338217

Early Treatment of Skeletal Anterior Open Bite by Two Appliances

Open bite is a common dentoalveolar component of the facial pattern of the excessive vertical dimension patients that is also known as the gaping angle face pattern.It is a deformation in the vertical relationship between the upper and the lower dental arches that is characterized by the loss of contact between the opposite dental segments.

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Key information

Conditions

Open Bite Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontic Department, University of Al-Baath Dental School

Hama, Hamah, 12JO76WH, Syria

About this study

An open bite develops as a result of the interaction of many etiologic factors, both hereditary and environmental. Prolonged sucking habits and hyper-divergent facial characteristics are significant risk factors for an anterior open bite in the mixed dentition. Abnormal tongue posture (frequently associated with enlarged adenoids or tonsils) and tongue thrust also can be involved in the establishment of alveolar and skeletal discrepancies concurrent with vertical problems Two types of an open bite are recognized in this profession: (1) dentoalveolar open bite: the abnormality formalities aspects limiting in the dental and alveolar region, usually associated with abnormal function habits as the thumb sucking and (2) Skeletal open bite: that's associated with an over high of the lower facial vertical dimension and a large plane angle of the lower jaw. open bites associated with excessive vertical skeletal dimensions are difficult to treat and tend to relapse The investigators must be recognized between the dentoalveolar open bite and the open bite caused by formalities disorders and the position disorders of the upper or the lower jaw or both. Dental an open bite can be corrected by itself if the treatment was beginning early and it's responding Easley to the mechanical treatment methods and the functional treatment approaches that depending on the muscular activity

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Anterior open bite (2-10) mm.
  • Skeletal Class I or II malocclusion.
  • MP-SN angle ranged between (33-45) degrees.
  • MM angle ranged between (27-37) degrees.
  • Age between 7.5-10.5 years.

Exclusion criteria

  • Patients who had an old orthodontic treatment
  • People with a syndrome or congenital deformity

Treatment and study plan

Bionator

Device

This is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity

Removable Appliance with Posterior Bite Planes

Device

This is a one-jaw appliance that is used in conjunction with a tongue crib to control the faulty positions of the tongue and to help in closing the open bite through the use of posterior bite planes.

Primary outcomes

  1. Change in the SNA angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the position of upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and A.

  2. Change in the SNB angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This anglrepresents the position of lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between points S, N, and B.

  3. Change in the ANB angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between A, N, and B.

  4. Changes in the MM angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the maxillary plane and mandibular plane.

  5. Changes in the SN-OCP angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the occlusion plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the SN plane (anterior cranial base plane) and the OCP (occlusal) plane.

  6. Changes in the SN-MP angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the lower jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the mandibular plane (MP plane).

  7. Changes in the SN-SPP angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the upper jaw plane and the cranial base in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (SN plane) and the maxillary plane (SPP plane).

  8. Changes in the overbite (Ovb)

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This is a vertical measurement done on the cephalometric tracings in millimeters.

    It is the vertical overlap between the upper incisors and the lower incisors.

  9. Changes in the overjet (Ovj)

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This is a horizontal measurement done on the cephalometric tracings in millimeters.

    It is the amount of protrusion of upper incisors in relation to the lower incisors.

  10. Changes in the Bjork sum

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    Lateral cephalograms will be taken twice and this measurement is the sum of three different angles: (N-S-Ar + S-Ar-Go +Ar-Go-Me). These angles are well-known to orthodontists.

  11. Changes in the N-A-Pog angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between three points: N, A, and Pogonion (Pog).

    N is located on the nasal bone. A is located at the maximum concavity of the anterior upper alveolus between the central incisors.

    Pog is the located at the most prominent point on the chin contour.

  12. Changes in the UI- LI angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the upper and the lower incisor axes in the cephalometric analysis. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the long axis of the upper incisor and the long axis of the lower incisor.

  13. Changes in the NS-GN angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the growth pattern of the mandible in the cephalometric analysis in the vertical direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the anterior cranial base plane (NS plane) and the the Y-axis plane (i.e. the facial axis plane defined by two points: Sella Point and Gnathion 'Gn' Point).

  14. Changes in the posterior facial height (S-Go)

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This will be vertically measured in millimeters from S point to Go point. 'S' point referes to Sella Turcica point. 'Go' point refers to the gonial angle point (located at the corner of the mandibular ramus).

  15. Changes in the anterior facial height (N-Me)

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This will be vertically measured in millimeters from N point to Me point. 'N' point refers to the Nasion point. 'Me' point refers to the Menton point (located at the lower border of the chin).

  16. Changes in the 'NasoLab' angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the nose and the upper lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between the lower nasal tangent (i.e. the plane that touches the lower border of the columella), and the upper lip plane (i.e. the plane that goes through points Subnasale and Labrale Superius).

  17. Changes in the 'MentoLab' angle

    Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

    This angle represents the relationship between the chin and the lower lip in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken twice and this angle is going to be measured in degrees between two planes: the lower lip tangent plane (from 'Labrale inferius' to mentolabial point) and upper anterior chin plane (from mentolabial point to Pogonion point).

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Open-bite Bionator Versus the Removable Posterior Bite Plane With a Tongue Crib in the Early Treatment of Skeletal Anterior Open Bite: A Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2020
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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