An interventional study of Bionator and Removable Appliance with Posterior Bite Planes in Open Bite, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Damascus University · Not applicable, Interventional, and Treatment
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.
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
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 40 is above the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.
Device: Bionator
A removable appliance with poster bite planes was used to correct the open bite malocclusion. Patients were asked to wear this appliance full time expect eating times.
Device: Removable Appliance with Posterior Bite Planes
This is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity
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.
Change in the SNA angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Change in the SNB angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Change in the ANB angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the MM angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the SN-OCP angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the SN-MP angle
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the SN-SPP angle
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the overbite (Ovb)
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the overjet (Ovj)
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the Bjork sum
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the N-A-Pog angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the UI- LI angle
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.
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the NS-GN angle
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the posterior facial height (S-Go)
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the anterior facial height (N-Me)
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the 'NasoLab' angle
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Changes in the 'MentoLab' angle
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).
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Plan to share: No
Ran from Aug 2017 to primary completion in Jun 2018, 10 months.
Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 10 months is below that.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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