Clinical trial NCT04338217: Early Treatment of Skeletal Anterior Open Bite by Two Appliances
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Bite
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Change in the SNA angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Change in the SNB angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Change in the ANB angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the MM angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the SN-OCP angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the SN-MP angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the SN-SPP angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the overbite (Ovb)
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the overjet (Ovj)
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the Bjork sum
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the N-A-Pog angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the UI- LI angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the NS-GN angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the posterior facial height (S-Go)
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the anterior facial height (N-Me)
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the 'NasoLab' angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
measure: Changes in the 'MentoLab' angle
timeFrame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Hama
country: Syrian Arab Republic
facility: Orthodontic Department, University of Al-Baath Dental School
state: Hamah
Study officials:
affiliation: PhD student, Orthodontics Department, University of Damascus Dental School
name: Mahran Raheel Mousa, DDS MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Hama, Hama, Syria
name: Hassan Farah, DDS MSc PhD
role: STUDY_CHAIR
References:
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. doi: 10.1093/ejo/cjl053. Epub 2006 Nov 13.
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. doi: 10.1016/j.ajodo.2005.12.035.
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.
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. doi: 10.1016/j.ajodo.2005.11.045.
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.
citation: 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. doi: 10.1016/j.ajodo.2006.02.004.
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.
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.
citation: Mousa MR, Hajeer MY, Farah H. 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. J World Fed Orthod. 2021 Dec;10(4):163-171. doi: 10.1016/j.ejwf.2021.08.001. Epub 2021 Aug 27.