Early Treatment of Skeletal Anterior Open Bite by Two Appliances

NCT ID: NCT04338217

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-15
• Study Completion Date: 2018-09-12

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

Conditions

Open Bite

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bionator

The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.

Group Type: EXPERIMENTAL

Bionator

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Removable Appliance with Posterior Bite Planes

Intervention Type: 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.

Interventions

Bionator

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

Intervention Type: DEVICE

Removable Appliance with Posterior Bite Planes

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahran Raheel Mousa, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

PhD student, Orthodontics Department, University of Damascus Dental School

Hassan Farah, DDS MSc PhD

Role: STUDY_CHAIR

Professor of Orthodontics, University of Hama, Hama, Syria

Locations

Orthodontic Department, University of Al-Baath Dental School

Hama, Hama Governorate, Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 17101701 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18005832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19915269 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18068591 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27141934 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16769491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29911909 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18174075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34462242 (View on PubMed)

Other Identifiers

UDDS-Ortho-02-2020

Identifier Type: -

Identifier Source: org_study_id