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Skeletal MalocclusionNCT03824574

Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design

A study testing Clear Mandibular Advancement Appliance in people with Skeletal Malocclusion, run by Ain Shams University.

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 study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency. Read more about this study

Who is it for?
Ages 8 to 12 years, women only
Conditions the study is for
Skeletal Malocclusion
What is being tested?
Clear Mandibular Advancement Appliance
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
20 Sep 2016to 4 Mar 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 8 to 12 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Gender: Female subjects.
  • Chronological age: All recruited subjects were between the ages of 8-12 years.
  • Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion with normal maxilla and retrognathic mandible were selected. This was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (Co-Gn) according to McNamara composite , SNB<78, SNA=82+2.
  • Dental characteristics:
  • Angle Class II molar relationship ranging from edge to edge to full unit Class II.
  • Overjet ranging between 5-10 mm.
Show all 10Show fewer
  • Absence of posterior crossbite and/or tendency for posterior crossbite.
  • Skeletal maturation stage: The growth stage for all subjects was selected to be before or at the prepubertal growth spurt. This was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before the end of the growth spurt.
  • No previous history of orthodontic treatment.
  • Absence of systemic diseases affecting growth or craniofacial development. -

Who cannot join

  • -

About this study

This study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency.

Read the detailed description

A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. Lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

Being tested
Clear Mandibular Advancement Appliance
Keywords
Functional appliance, skeletal class II, mandibular deficiency, twin-block, Growing patients, Clear appliance, Aligner
Medical subject headings
Micrognathism

What participants receive

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

  • Clear Mandibular Advancement ApplianceDevice

    Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible

Study groups in NCT03824574
Study groupRoleWhat they receive
Treatment armExperimentalSubjects receiving the clear mandibular advancement appliance
Receives: Device: Clear Mandibular Advancement Appliance

What is being measured

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

  1. Effective Mandibular Length

    Condylion-Gnathion

    Measured: 12 months

  2. Mandible to cranial base

    Sella-Nasion-B point

    Measured: 12 months

  3. Effective maxillary length

    Condylion-A point

    Measured: 12 months

  4. Maxilla to cranial base

    Sella-Nasion-A point

    Measured: 12 months

Secondary outcomes (7)

  1. Lower incisor inclination

    Lower incisor to mandibular plane

    Measured: 12 months

  2. Lower incisor AP position

    Lower incisor Anteroposterior position

    Measured: 12 months

  3. Upper incisor inclination

    Upper incisor to palatal plane

    Measured: 12 months

  4. Upper incisor AP position

    Upper incisor Anteroposterior position

    Measured: 12 months

  5. Profile convexity

    N'Sn/Sn-Pog'

    Measured: 12 months

  6. Lip protrusion

    Ls-E plane

    Measured: 12 months

  7. Chin position

    Soft tissue Pogonion position

    Measured: 12 months

Timeline

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

  1. First posted31 Jan 2019
  2. Study start20 Sep 2016
  3. Primary completion15 Dec 2017
  4. Study completion4 Mar 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03824574
Sponsor's protocol ID
AinShamsUOrthodontics
Status last verified
Jan 2019
First submitted
29 Jan 2019
Last updated
31 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jena AK, Duggal R, Parkash H. Skeletal and dentoalveolar effects of Twin-block and bionator appliances in the treatment of Class II malocclusion: a comparative study. Am J Orthod Dentofacial Orthop. 2006 Nov;130(5):594-602. doi: 10.1016/j.ajodo.2005.02.025.

    PubMed 17110256

  • Teuscher U. A growth-related concept for skeletal class II treatment. Am J Orthod. 1978 Sep;74(3):258-75. doi: 10.1016/0002-9416(78)90202-6.

    PubMed 281130

  • Lv Y, Yan B, Wang L. Two-phase treatment of skeletal class II malocclusion with the combination of the twin-block appliance and high-pull headgear. Am J Orthod Dentofacial Orthop. 2012 Aug;142(2):246-55. doi: 10.1016/j.ajodo.2010.12.024.

    PubMed 22858335

  • O'Brien K, Macfarlane T, Wright J, Conboy F, Appelbe P, Birnie D, Chadwick S, Connolly I, Hammond M, Harradine N, Lewis D, Littlewood S, McDade C, Mitchell L, Murray A, O'Neill J, Sandler J, Read M, Robinson S, Shaw I, Turbill E. Early treatment for Class II malocclusion and perceived improvements in facial profile. Am J Orthod Dentofacial Orthop. 2009 May;135(5):580-5. doi: 10.1016/j.ajodo.2008.02.020.

    PubMed 19409340

  • Tulloch JF, Phillips C, Koch G, Proffit WR. The effect of early intervention on skeletal pattern in Class II malocclusion: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 1997 Apr;111(4):391-400. doi: 10.1016/s0889-5406(97)80021-2.

    PubMed 9109584

  • Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.

    PubMed 16679196

  • Baccetti T, Franchi L, Toth LR, McNamara JA Jr. Treatment timing for Twin-block therapy. Am J Orthod Dentofacial Orthop. 2000 Aug;118(2):159-70. doi: 10.1067/mod.2000.105571.

    PubMed 10935956

  • Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.

    PubMed 3422118

  • Toth LR, McNamara JA Jr. Treatment effects produced by the twin-block appliance and the FR-2 appliance of Frankel compared with an untreated Class II sample. Am J Orthod Dentofacial Orthop. 1999 Dec;116(6):597-609. doi: 10.1016/s0889-5406(99)70193-9.

    PubMed 10587592

  • Trenouth MJ. Cephalometric evaluation of the Twin-block appliance in the treatment of Class II Division 1 malocclusion with matched normative growth data. Am J Orthod Dentofacial Orthop. 2000 Jan;117(1):54-9. doi: 10.1016/s0889-5406(00)70248-4.

    PubMed 10629520

  • Mills CM, McCulloch KJ. Posttreatment changes after successful correction of Class II malocclusions with the twin block appliance. Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):24-33. doi: 10.1067/mod.2000.104902.

    PubMed 10893470

  • Singh GD, Hodge MR. Bimaxillary morphometry of patients with class II division 1 malocclusion treated with twin block appliances. Angle Orthod. 2002 Oct;72(5):402-9. doi: 10.1043/0003-3219(2002)0722.0.CO;2.

    PubMed 12401048

  • Schaefer AT, McNamara JA Jr, Franchi L, Baccetti T. A cephalometric comparison of treatment with the Twin-block and stainless steel crown Herbst appliances followed by fixed appliance therapy. Am J Orthod Dentofacial Orthop. 2004 Jul;126(1):7-15. doi: 10.1016/j.ajodo.2003.06.017.

    PubMed 15224053

  • O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.

    PubMed 12923506

  • Flores-Mir C, Major PW. Cephalometric facial soft tissue changes with the twin block appliance in Class II division 1 malocclusion patients. A systematic review. Angle Orthod. 2006 Sep;76(5):876-81. doi: 10.1043/0003-3219(2006)076[0876:CFSTCW]2.0.CO;2.

    PubMed 17029526

Questions about this trial

What is this clinical trial studying?

A study testing Clear Mandibular Advancement Appliance in people with Skeletal Malocclusion, run by Ain Shams University.

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 10 inclusion and 1 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 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Effective Mandibular Length (time frame: 12 months). The study lists 4 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 NCT03824574, which also lists 17 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 31 Jan 2019.

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