Early Treatment of Skeletal Anterior Open Bite by Two Appliances

NCT04338217 | Completed DMC

• 1 other identifier: UDDS-Ortho-02-2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Bite

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Bionator

EXPERIMENTAL

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

Device: Bionator

Removable Appliance with Posterior Bite Planes

ACTIVE COMPARATOR

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

Interventions

Bionator DEVICE

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

Bionator

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.

Removable Appliance with Posterior Bite Planes

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontic Department, University of Al-Baath Dental School

Hama, Hamah, 12JO76WH, Syria

Location

Related Publications (9)

• 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.

  PMID: 17101701 BACKGROUND

• 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.

  PMID: 18005832 BACKGROUND

• 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.

  PMID: 19915269 BACKGROUND

• 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.

  PMID: 18068591 BACKGROUND

• 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.

  PMID: 27141934 BACKGROUND

• 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.

  PMID: 16769491 BACKGROUND

• 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.

  PMID: 29911909 BACKGROUND

• 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.

  PMID: 18174075 BACKGROUND

• 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.

  PMID: 34462242 DERIVED

MeSH Terms

Conditions

Open Bite

Interventions

Activator Appliances

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, Functional; Orthodontic Appliances; Orthodontics; Dentistry; Orthodontic Appliances, Removable

Study Officials

• Mahran Raheel Mousa, DDS MSc

  PhD student, Orthodontics Department, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Hassan Farah, DDS MSc PhD

  Professor of Orthodontics, University of Hama, Hama, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 8, 2020
• Study Start: August 15, 2017
• Primary Completion: June 20, 2018
• Study Completion: September 12, 2018
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)