Open BiteNCT04338217

Early Treatment of Skeletal Anterior Open Bite by Two Appliances

A study testing Bionator and Removable Appliance with Posterior Bite Planes in people with Open Bite, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 7 to 10 years
Conditions the study is for: Open Bite
What is being tested?: Bionator and Removable Appliance with Posterior Bite Planes
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSyria
Study dates: 15 Aug 2017to 12 Sep 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 10 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontic Department, University of Al-Baath Dental School
Hama, Hamah, 12JO76WH

Other trials in Syria

About this study

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

Read the 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
Being tested: Bionator, Removable Appliance with Posterior Bite Planes
Medical subject headings: Open Bite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BionatorDevice
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 PlanesDevice
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.

Study groups in NCT04338217
Study group	Role	What they receive
Bionator	Experimental	The modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day. Receives: 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. Receives: Device: Removable Appliance with Posterior Bite Planes

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201712 Sep 2018

First posted8 Apr 2020
Study start15 Aug 2017
Primary completion20 Jun 2018
Study completion12 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Open BiteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04338217
Sponsor's protocol ID: UDDS-Ortho-02-2020
Status last verified: Apr 2020
First submitted: 4 Apr 2020
Last updated: 8 Apr 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 17101701
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.
PubMed 18005832
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.
PubMed 19915269
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.
PubMed 18068591
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.
PubMed 27141934
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.
PubMed 16769491
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.
PubMed 29911909
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.
PubMed 18174075
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.
PubMed 34462242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Open Bite trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04338217
Acronym / sponsor ID: UDDS-Ortho-02-2020
Conditions: Open Bite
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 15 Aug 2017 (actual)
Primary completion: 20 Jun 2018 (actual)
Study completion: 12 Sep 2018 (actual)
First posted: 8 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Bionator	Experimental	Device: BionatorThe modified Bionator was used to correct the open bite malocclusion. Patients were asked to wear the appliance every day.
Removable Appliance with Posterior Bite Planes	Active comparator	Device: Removable Appliance with Posterior Bite PlanesA 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.

Who may qualify

Ages: 7 to 10 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BionatorThis is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity	Device	Bionator
Removable Appliance with Posterior Bite PlanesThis 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.	Device	Removable Appliance with Posterior Bite Planes

Primary outcome

Change in the SNA angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Change in the SNB angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Change in the ANB angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the MM angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the SN-OCP angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the SN-MP angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the SN-SPP angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the overbite (Ovb)
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the overjet (Ovj)
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the Bjork sum
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the N-A-Pog angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the UI- LI angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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.
Changes in the NS-GN angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the posterior facial height (S-Go)
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the anterior facial height (N-Me)
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the 'NasoLab' angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).
Changes in the 'MentoLab' angle
Time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session
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).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
Background: PubMed 17101701Torres 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.
Background: PubMed 18005832Defraia 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.
Background: PubMed 19915269Meibodi 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.
Background: PubMed 18068591Cozza 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.
Background: PubMed 27141934Mucedero 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.
Background: PubMed 16769491Cozza 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.
Background: PubMed 29911909Rossato 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.
Background: PubMed 18174075Giuntini 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.
Derived from this study: PubMed 34462242Mousa 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mahran Raheel Mousa, DDS MSc principal investigator

PhD student, Orthodontics Department, University of Damascus Dental School

Hassan Farah, DDS MSc PhD study chair

Professor of Orthodontics, University of Hama, Hama, Syria

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bionator and Removable Appliance with Posterior Bite Planes in people with Open Bite, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the SNA angle (time frame: T1: one day before the beginning of treatment; T2: within two hours after the last treatment session). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04338217, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.