Open Bite Clinical Trial
Official 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
Verified date | April 2020 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 12, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 10 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Orthodontic Department, University of Al-Baath Dental School | Hama | Hamah |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Cozza P, Baccetti T, Franchi L, McNamara JA Jr. Treatment effects of a modified quad-helix in patients with dentoskeletal open bites. Am J Orthod Dentofacial Orthop. 2006 Jun;129(6):734-9. — View Citation
Cozza P, Baccetti T, Franchi L, Mucedero M. Comparison of 2 early treatment protocols for open-bite malocclusions. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):743-7. — View Citation
Defraia E, Marinelli A, Baroni G, Franchi L, Baccetti T. Early orthodontic treatment of skeletal open-bite malocclusion with the open-bite bionator: a cephalometric study. Am J Orthod Dentofacial Orthop. 2007 Nov;132(5):595-8. — View Citation
Giuntini V, Franchi L, Baccetti T, Mucedero M, Cozza P. Dentoskeletal changes associated with fixed and removable appliances with a crib in open-bite patients in the mixed dentition. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):77-80. doi: 10.1016/j.ajodo.2007.07.012. — View Citation
Meibodi SE, Fatahi Meybodi S, Samadi AH. The effect of posterior bite-plane on dentoskeletal changes in skeletal open-bite malocclusion. J Indian Soc Pedod Prev Dent. 2009 Oct-Dec;27(4):202-4. doi: 10.4103/0970-4388.57653. — View Citation
Mucedero M, Vitale M, Franchi L, Cozza P, Perillo L. Comparisons of two protocols for early treatment of anterior open bite. Eur J Orthod. 2017 Jun 1;39(3):270-276. doi: 10.1093/ejo/cjw039. — View Citation
Rossato PH, Fernandes TMF, Urnau FDA, de Castro AC, Conti F, de Almeida RR, Oltramari-Navarro PVP. Dentoalveolar effects produced by different appliances on early treatment of anterior open bite: A randomized clinical trial. Angle Orthod. 2018 Nov;88(6):684-691. doi: 10.2319/101317-691.1. Epub 2018 Jun 18. — View Citation
Torres F, Almeida RR, de Almeida MR, Almeida-Pedrin RR, Pedrin F, Henriques JF. Anterior open bite treated with a palatal crib and high-pull chin cup therapy. A prospective randomized study. Eur J Orthod. 2006 Dec;28(6):610-7. Epub 2006 Nov 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. |
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. |
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. |
T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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. | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session | |
Primary | 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). | T1: one day before the beginning of treatment; T2: within two hours after the last treatment session |
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