NCT02456220

Brief Summary

The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG), in comparison with a Class II comparison group (CG). 3D virtual models generated from three time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II malocclusion patients, in the same stage of biologic maturation and skeletal abnormality, but with no orthopedic treatment will be constructed for the CG subjects. These CG patients are under orthodontic treatment, but only with teeth alignment. Voxel based registration on the anterior cranial fossa will be used to assess maxillary and mandibular displacement/articular fossa remodeling; regional registration on the mandibular corpus will be performed to evaluate mandibular growth and mandibular dental changes; and regional registration on the anterior region of the maxilla will be performed to evaluate maxillary growth and maxillary dental changes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

May 25, 2015

Last Update Submit

October 24, 2015

Conditions

Malocclusion, Angle Class II

Keywords

Herbst applianceComputed tomography3D imagingGrowth and developmentOrthodontic Appliances, Functional

Outcome Measures

Primary Outcomes (1)

  • Skeletal mandibular growth after Herbst appliance therapy

    To test the mandibular rotation immediately after Herbst appliance insertion; and 2) to compare the displacement of the condyles with the reduction of overjet (OJ) and overbite (OB). Virtual 3D surface models of 25 subjects were generated from the cone-beam computed tomographs taken before treatment, and immediately after Herbst installation. Scans were registered on the cranial bases, and analyzed using point-to-point measurements, color-coded maps and semitransparent overlays.

    8 months

Secondary Outcomes (5)

  • Mandibular displacement after Herbst appliance therapy

    8 months

  • Displacement of the mandibular condyles immediately after Herbst appliance insertion - 3D assessment

    5 weeks

  • Maxillary displacement after Herbst appliance therapy

    8 months

  • Bone remodeling of the articular fossae after Herbst appliance therapy

    8 months

  • Dental positional changes after Herbst appliance therapy

    8 months

Study Arms (2)

Herbst Group

EXPERIMENTAL

Patients treated with Herbst appliance.

Device: Herbst appliance

Comparison Group

NO INTERVENTION

Patients that received only teeth movement (alignment and leveling before Herbst insertion), without any orthopedic intervention.

Interventions

Herbst applianceDEVICE

Group treated with conventional Herbst appliance for mandibular advancement during orthopedic treatment.

Herbst Group

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Class II malocclusion with mandibular retrognathism
  • Convex Profile
  • Pubertal period
  • Permanent dentition
  • Parental permission with a signed consent form

You may not qualify if:

  • Syndromic patients
  • Previous orthopedic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontifícia Universidade Católica de Minas Gerais

Belo Horizonte, Minas Gerais, 30.535.610, Brazil

Location

Related Publications (30)

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    PMID: 3181302BACKGROUND

  • Buschang PH, Martins J. Childhood and adolescent changes of skeletal relationships. Angle Orthod. 1998 Jun;68(3):199-206; discussion 207-8. doi: 10.1043/0003-3219(1998)0682.3.CO;2.

    PMID: 9622756BACKGROUND

  • Cevidanes LH, Oliveira AE, Grauer D, Styner M, Proffit WR. Clinical application of 3D imaging for assessment of treatment outcomes. Semin Orthod. 2011 Mar 1;17(1):72-80. doi: 10.1053/j.sodo.2010.08.012.

    PMID: 21516170BACKGROUND

  • Cevidanes LH, Heymann G, Cornelis MA, DeClerck HJ, Tulloch JF. Superimposition of 3-dimensional cone-beam computed tomography models of growing patients. Am J Orthod Dentofacial Orthop. 2009 Jul;136(1):94-9. doi: 10.1016/j.ajodo.2009.01.018.

    PMID: 19577154BACKGROUND

  • Hagg U, Rabie AB, Bendeus M, Wong RW, Wey MC, Du X, Peng J. Condylar growth and mandibular positioning with stepwise vs maximum advancement. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):525-36. doi: 10.1016/j.ajodo.2006.09.064.

    PMID: 18929270BACKGROUND

  • Hagg U, Pancherz H. Dentofacial orthopaedics in relation to chronological age, growth period and skeletal development. An analysis of 72 male patients with Class II division 1 malocclusion treated with the Herbst appliance. Eur J Orthod. 1988 Aug;10(3):169-76. doi: 10.1093/ejo/10.3.169. No abstract available.

    PMID: 3181295BACKGROUND

  • Kinzinger G, Kober C, Diedrich P. Topography and morphology of the mandibular condyle during fixed functional orthopedic treatment --a magnetic resonance imaging study. J Orofac Orthop. 2007 Mar;68(2):124-47. doi: 10.1007/s00056-007-0650-0. English, German.

    PMID: 17372710BACKGROUND

  • LeCornu M, Cevidanes LH, Zhu H, Wu CD, Larson B, Nguyen T. Three-dimensional treatment outcomes in Class II patients treated with the Herbst appliance: a pilot study. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):818-30. doi: 10.1016/j.ajodo.2013.07.014.

    PMID: 24286905BACKGROUND

  • Pancherz H, Malmgren O, Hagg U, Omblus J, Hansen K. Class II correction in Herbst and Bass therapy. Eur J Orthod. 1989 Feb;11(1):17-30. doi: 10.1093/oxfordjournals.ejo.a035960.

    PMID: 2714389BACKGROUND

  • Pancherz H. The effect of continuous bite jumping on the dentofacial complex: a follow-up study after Herbst appliance treatment of class II malocclusions. Eur J Orthod. 1981;3(1):49-60. doi: 10.1093/ejo/3.1.49. No abstract available.

    PMID: 6939593BACKGROUND

  • Pancherz H. The mechanism of Class II correction in Herbst appliance treatment. A cephalometric investigation. Am J Orthod. 1982 Aug;82(2):104-13. doi: 10.1016/0002-9416(82)90489-4.

    PMID: 6961781BACKGROUND

  • Pancherz H. Vertical dentofacial changes during Herbst appliance treatment. A cephalometric investigation. Swed Dent J Suppl. 1982;15:189-96.

    PMID: 6963773BACKGROUND

  • Pancherz H. The Herbst appliance--its biologic effects and clinical use. Am J Orthod. 1985 Jan;87(1):1-20. doi: 10.1016/0002-9416(85)90169-1.

    PMID: 3855346BACKGROUND

  • Pancherz H. The nature of Class II relapse after Herbst appliance treatment: a cephalometric long-term investigation. Am J Orthod Dentofacial Orthop. 1991 Sep;100(3):220-33. doi: 10.1016/0889-5406(91)70059-6.

    PMID: 1877546BACKGROUND

  • Pancherz H, Anehus-Pancherz M. Muscle activity in class II, division 1 malocclusions treated by bite jumping with the Herbst appliance. An electromyographic study. Am J Orthod. 1980 Sep;78(3):321-9. doi: 10.1016/0002-9416(80)90277-8. No abstract available.

    PMID: 6931496BACKGROUND

  • Pancherz H, Fackel U. The skeletofacial growth pattern pre- and post-dentofacial orthopaedics. A long-term study of Class II malocclusions treated with the Herbst appliance. Eur J Orthod. 1990 May;12(2):209-18. doi: 10.1093/ejo/12.2.209.

    PMID: 2351206BACKGROUND

  • Pancherz H, Fischer S. Amount and direction of temporomandibular joint growth changes in Herbst treatment: a cephalometric long-term investigation. Angle Orthod. 2003 Oct;73(5):493-501. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

    PMID: 14580015BACKGROUND

  • Pancherz H, Hagg U. Dentofacial orthopedics in relation to somatic maturation. An analysis of 70 consecutive cases treated with the Herbst appliance. Am J Orthod. 1985 Oct;88(4):273-87. doi: 10.1016/0002-9416(85)90126-5.

    PMID: 3863486BACKGROUND

  • Pancherz H, Hansen K. Mandibular anchorage in Herbst treatment. Eur J Orthod. 1988 May;10(2):149-64. doi: 10.1093/ejo/10.2.149. No abstract available.

    PMID: 3164681BACKGROUND

  • Pancherz H, Hansen K. Occlusal changes during and after Herbst treatment: a cephalometric investigation. Eur J Orthod. 1986 Nov;8(4):215-28. doi: 10.1093/ejo/8.4.215. No abstract available.

    PMID: 3466794BACKGROUND

  • Pancherz H, Ruf S, Kohlhas P. "Effective condylar growth" and chin position changes in Herbst treatment: a cephalometric roentgenographic long-term study. Am J Orthod Dentofacial Orthop. 1998 Oct;114(4):437-46. doi: 10.1016/s0889-5406(98)70190-8.

    PMID: 9790329BACKGROUND

  • Rabie AB, Tsai MJ, Hagg U, Du X, Chou BW. The correlation of replicating cells and osteogenesis in the condyle during stepwise advancement. Angle Orthod. 2003 Aug;73(4):457-65. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

    PMID: 12940568BACKGROUND

  • Ruf S, Pancherz H. Temporomandibular joint growth adaptation in Herbst treatment: a prospective magnetic resonance imaging and cephalometric roentgenographic study. Eur J Orthod. 1998 Aug;20(4):375-88. doi: 10.1093/ejo/20.4.375.

    PMID: 9753819BACKGROUND

  • Ruf S, Pancherz H. Temporomandibular joint remodeling in adolescents and young adults during Herbst treatment: A prospective longitudinal magnetic resonance imaging and cephalometric radiographic investigation. Am J Orthod Dentofacial Orthop. 1999 Jun;115(6):607-18. doi: 10.1016/s0889-5406(99)70285-4.

    PMID: 10358242BACKGROUND

  • Ruf S, Pancherz H. Herbst/multibracket appliance treatment of Class II division 1 malocclusions in early and late adulthood. a prospective cephalometric study of consecutively treated subjects. Eur J Orthod. 2006 Aug;28(4):352-60. doi: 10.1093/ejo/cji116. Epub 2006 Apr 27.

    PMID: 16644850BACKGROUND

  • Ruf S, Wusten B, Pancherz H. Temporomandibular joint effects of activator treatment: a prospective longitudinal magnetic resonance imaging and clinical study. Angle Orthod. 2002 Dec;72(6):527-40. doi: 10.1043/0003-3219(2002)0722.0.CO;2.

    PMID: 12518944BACKGROUND

  • Serbesis-Tsarudis C, Pancherz H. "Effective" TMJ and chin position changes in Class II treatment. Angle Orthod. 2008 Sep;78(5):813-8. doi: 10.2319/082707-391.1.

    PMID: 18298212BACKGROUND

  • Voudouris JC, Woodside DG, Altuna G, Kuftinec MM, Angelopoulos G, Bourque PJ. Condyle-fossa modifications and muscle interactions during herbst treatment, part 1. New technological methods. Am J Orthod Dentofacial Orthop. 2003 Jun;123(6):604-13. doi: 10.1016/s0889-5406(03)00149-5.

    PMID: 12806337BACKGROUND

  • Voudouris JC, Woodside DG, Altuna G, Angelopoulos G, Bourque PJ, Lacouture CY, Kuftinec MM. Condyle-fossa modifications and muscle interactions during Herbst treatment, Part 2. Results and conclusions. Am J Orthod Dentofacial Orthop. 2003 Jul;124(1):13-29. doi: 10.1016/s0889-5406(03)00150-1.

    PMID: 12867894BACKGROUND

  • Woodside DG, Metaxas A, Altuna G. The influence of functional appliance therapy on glenoid fossa remodeling. Am J Orthod Dentofacial Orthop. 1987 Sep;92(3):181-98. doi: 10.1016/0889-5406(87)90411-2.

    PMID: 3477085BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontic Appliances, Functional

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Bernardo Q Souki, PhD

    Pontifícia Universidade Católica de Minas Gerais

    PRINCIPAL INVESTIGATOR

  • James A McNamara Jr., PhD

    University of Michigan

    STUDY DIRECTOR

  • Lucia Helena S Cevidanes, PhD

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

BR(1)