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Anterior Open BiteNCT02865213

Molar Intrusion in Open Bite Treatment

A study testing OBA, Miniplates and Miniscrews in people with Anterior 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
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Trial summary

This experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. The study sample will consist of 45 patients with anterior open bite. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Anterior Open Bite
What is being tested?
OBA, Miniplates and Miniscrews
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSyria
Study dates
Jan 2016to Nov 2017
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients with skeletal open bite determined by an increased B angle (angle between the maxillary plane and mandibular plane), the Sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
  • Patients between 12 and 18 years old in permanent dentition stage.
  • Negative over-bite of more than a mm
  • Class I or Class II skeletal anteroposterior relationship.

Who cannot join

  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Class III skeletal anteroposterior relationship.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Damascus University

    Damascus, 00963

Other trials in Syria

About this study

Official title: Assessment of Skeletal and Dentoalveolar Changes Resulting From Posterior Teeth Intrusion in Treatment of the Anterior Open Bite - a Randomized Controlled Trial

This experimental study will evaluate the effect of different methods for the molar intrusion (compared with the control group) in adolescent and adult patients with open bite malocclusion. The study sample will consist of 45 patients with anterior open bite. The sample will be randomly allocated into two experimental groups, in addition to a control group.

The investigators will apply a modified version of the Open Bite Appliance (OBA), by Erverdi and Usumez, for all patients in upper posterior teeth. For this purpose, miniplates will be used in the first treatment group, while miniscrews will be used in the second treatment group. In the control group, only OBA will be used. The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs. Pre- and post- treatment changes for each group will be evaluated, in addition to the comparison of the post-treatment skeletal and dental changes that occurs between groups.

Read the detailed description

Open bite malocclusion is considered one of the most difficult orthodontic problems to correct because it appears as a result of the interaction of numerous etiological factors (genetic, dental, skeletal, functional, soft tissue, and habit) that contribute to its development. Various therapeutic approaches have been proposed for the treatment of an anterior open bite. These approaches vary depending on the causative factors and involve myotherapy, preventive treatment, functional therapy, orthognathic surgery, and orthodontic treatment using anterior teeth extrusion or posterior teeth intrusion. Among the non-surgical orthodontic treatment methods are the temporary anchorage devices (TADs) including miniplates and miniscrew or micro-screw implants. The intrusion of posterior teeth with temporary anchorage devices was suggested to lead to decreased lower facial height by a counterclockwise rotation of the mandible; this may resemble the orthognathic surgery outcomes for any open bite patients. To the best of the investigators current knowledge, this is the first randomized controlled trial evaluating the effect of molar intrusion in adolescence and adult patients in the permanent dentition stage.

Being tested
OBA, Miniplates, Miniscrews
Keywords
Open bite, Molar intrusion, Temporary anchorage devices
Medical subject headings
Open Bite

What participants receive

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

  • OBADevice

    The intrusion of posterior teeth using removable appliance "OBA".

  • MiniplatesDevice

    The intrusion of posterior teeth using temporary anchorage "Miniplates".

  • MiniscrewsDevice

    The intrusion of posterior teeth using temporary anchorage "Miniscrews".

Study groups in NCT02865213
Study groupRoleWhat they receive
Miniplates + OBAExperimentalThe intrusion of posterior teeth using Miniplates + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniplates. The miniplates are for Jeil Dual top® anchor system, Jeil medical corporation, #702,kolon science valley 2nd, 811, Guro-Dong, Guro-Gu, Seoul, 152-050, Korea. Tel: 82.2.850.3500. Fax: 82.2.850.3537. homepage: www.jeilmed.co.kr/ E-mail: mktg@jeilmed.co.kr
Receives: Device: OBA; Device: Miniplates
Miniscrews + OBAExperimentalThe intrusion of posterior teeth using Miniscrews + OBA will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth and miniscrews. The miniscrews are for Denxy ® dental orthodontic products, Denxy technology co, limited . 404,Lihuabuilding,Furongroad, Changsha, Hunan, China. Tel: 0086-731-89717339. Fax: 0086-731-82237315. Homepage: www.denxy-orthodontic.com/email: DENXYDENTALBOSS@126.COM
Receives: Device: OBA; Device: Miniscrews
Only OBAExperimentalThe intrusion of posterior teeth using OBA only will be performed. The investigators will apply a modified version of the OBA (Open Bite Appliance), by Erverdi and Usumez, for all patients in upper posterior teeth only.
Receives: Device: OBA

What is being measured

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

  1. Overbite

    The distance between the incisal edges of upper incisors and the incisal edges of the lower incisors, measured in mm

    Measured: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

Secondary outcomes (4)

  1. Molar intrusion

    The vertical distance between upper molars and the true horizontal plane (measured in mm).

    Measured: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

  2. Mandibular autorotation

    This variable will be measured by superimposition of the anterior cranial base.

    Measured: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

  3. Anterior facial height

    The distance between the point "N" and the point "Me"

    Measured: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

  4. Change in the anteroposterior position of the point "B"

    The horizontal distance between point "B" and the true vertical plane.

    Measured: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months

Timeline

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

  1. First posted12 Aug 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionAug 2017
  4. Study completionNov 2017

Resources

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02865213
Sponsor's protocol ID
UDDS-Ortho-01-2016
Status last verified
Dec 2017
First submitted
22 Jul 2016
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: No Individual participant data will be only available to the researchers in the department of Orthodontics, Damascus University

Publications

  • Ng J, Major PW, Flores-Mir C. True molar intrusion attained during orthodontic treatment: a systematic review. Am J Orthod Dentofacial Orthop. 2006 Dec;130(6):709-14. doi: 10.1016/j.ajodo.2005.05.049.

    PubMed 17169732

  • Sugawara J, Baik UB, Umemori M, Takahashi I, Nagasaka H, Kawamura H, Mitani H. Treatment and posttreatment dentoalveolar changes following intrusion of mandibular molars with application of a skeletal anchorage system (SAS) for open bite correction. Int J Adult Orthodon Orthognath Surg. 2002;17(4):243-53.

    PubMed 12592995

  • Deguchi T, Kurosaka H, Oikawa H, Kuroda S, Takahashi I, Yamashiro T, Takano-Yamamoto T. Comparison of orthodontic treatment outcomes in adults with skeletal open bite between conventional edgewise treatment and implant-anchored orthodontics. Am J Orthod Dentofacial Orthop. 2011 Apr;139(4 Suppl):S60-8. doi: 10.1016/j.ajodo.2009.04.029.

    PubMed 21435540

  • Akan S, Kocadereli I, Aktas A, Tasar F. Effects of maxillary molar intrusion with zygomatic anchorage on the stomatognathic system in anterior open bite patients. Eur J Orthod. 2013 Feb;35(1):93-102. doi: 10.1093/ejo/cjr081. Epub 2011 Aug 9.

    PubMed 21828357

  • Xun C, Zeng X, Wang X. Microscrew anchorage in skeletal anterior open-bite treatment. Angle Orthod. 2007 Jan;77(1):47-56. doi: 10.2319/010906-14R.1.

    PubMed 17029531

  • Erverdi N, Keles A, Nanda R. The use of skeletal anchorage in open bite treatment: a cephalometric evaluation. Angle Orthod. 2004 Jun;74(3):381-90. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

    PubMed 15264651

  • Hart TR, Cousley RR, Fishman LS, Tallents RH. Dentoskeletal changes following mini-implant molar intrusion in anterior open bite patients. Angle Orthod. 2015 Nov;85(6):941-8. doi: 10.2319/090514-625.1. Epub 2014 Dec 22.

    PubMed 25531420

  • Kuroda S, Katayama A, Takano-Yamamoto T. Severe anterior open-bite case treated using titanium screw anchorage. Angle Orthod. 2004 Aug;74(4):558-67. doi: 10.1043/0003-3219(2004)0742.0.CO;2.

    PubMed 15387036

Questions about this trial

What is this clinical trial studying?

A study testing OBA, Miniplates and Miniscrews in people with Anterior 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 4 inclusion and 3 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 3 Jan 2018. 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?

Overbite (time frame: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months). 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 NCT02865213, which also lists 8 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 3 Jan 2018.

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