Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00006354

Trial Description

start of 1:1-Block title

Title

Long-term stability after Class II treatment with the Herbst appliance

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Long-term stability Herbst treatment

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The aim of this study is to investigate the long-term stability of results obtained by Herbst appliance treatment. Therefore, the post-treatment changes of the masticatory system are to be investigated.

The Herbst appliance is a fixed functional orthodontic appliance causing permanent mandibular advancement which results in adaptation of the temporomandibular joint as well as the alveolar processes and therefore corrects mandibular retrusion and the respective Class II relation.

Individuals who received Herbst appliance treatment as well as subsequent multibracket appliance treatment at the Department of Orthodontics, University of Giessen are eligible to participate, if treatment with these appliances was completed at least 15 years ago.

In case of participation in this study, the current orthodontic diagnosis will be documented taking impressions of the upper and lower jaw. Furthermore, general oral health will be assessed by clinical inspection of oral mucosa and dental status. In addition, the temporomandibular joints and the masticatory muscles are to be assessed clinically as well as lower jaw mobility using a caliper. Finally, the facial profile will be recorded taking photographs.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To evaluate long-term stability after orthodontic (Class II) treatment with the Herbst appliance, dental and dentofacial changes which occurred during a post-treatment period of 15 years are to be analysed. Therefore, patients who received treatment at the Department of Orthodontics, University of Giessen which was completed at least 15 years ago, will be assessed in a clinical, non-interventional trial. The generated post-treatment data will be compared (as far as possible) to an untreated control group (Class I) of similar age.

Stability of sagittal and vertical incisor relationship, sagittal molar and canine relationship as well as changes of the facial profile, the current orthodontic diagnosis (PAR-Index), general oral health and temporomandibular joint function are to be assessed.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006354
  •   2014/07/21
  •   [---]*
  •   yes
  •   Approved
  •   146/13, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Class II malocclusion (stability after treatment)
  •   K07 -  Dentofacial anomalies [including malocclusion]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   (after) Herbst treatment; taking impressions to obtain study models, inspection of oral cavity, screening of temporomandibular joint and lower jaw mobility, taking photographs
  •   Class I occlusion (untreated); evaluation of orthodontic study models, no clinical assessment
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Prognosis
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Stability of overjet during the post-treatment observation period; changes > 1 millimeter compared to the control group are to be considered as clinically relevant (measurements performed on orthodontic study models).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Changes of overbite, sagittal molar- and canine relationship (assessment using orthodontic study models from before treatment, after treatment and after the post-treatment period);

Changes of facial profile (assessment from photographs from before treatment, after treatment and after the post-treatment period);

Evaluation of orthodontic diagnosis (PAR-Index) using orthodontic study models from before treatment, after treatment and after the post-treatment period);

Evaluation of general oral health and temporomandibular joint function as well as the current orthodontic treatment need by means of clinical inspection

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/04/15
  •   32
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Herbst patients: Orthodontic Herbst appliance treatment as well as subsequent multibracket appliance treatment, treatment completed at least 15 years ago, pre-treatment overjet ≥ 6mm and Class II molar relationship ≥ 0,5 cusp widths (bilaterally) / 1,0 cusp widths (unilaterally)
Control group: Class I occlusion, no orthodontic treatment, observation period of at least 15 years (documentation by orthodontic study models)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Failure of inclusion criteria, incomplete treatment records

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Justus-Liebig-Universität GiessenPoliklinik für Kieferorthopädie
    • Schlangenzahl 14
    • 35392  Giessen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • University of HelsinkiInstitue of Dentistry
    • Mannerheimintie 172
    • 00014  Helsinki
    • Finland
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Justus-Liebig-Universität GiessenPoliklinik für Kieferorthopädie
    • Mr.  Dr. med. dent.  Niko Christian  Bock 
    • Schlangenzahl 14
    • 35392  Giessen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Justus-Liebig-Universität GiessenPoliklinik für Kieferorthopädie
    • Mr.  Dr. med. dent.  Niko Christian  Bock 
    • Schlangenzahl 14
    • 35392  Giessen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde (Wissenschaftsfond)
    • Liesegangstrasse 17 a
    • 40211  Düsseldorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Justus-Liebig-Universität GiessenPoliklinik für Kieferorthopädie
    • Schlangenzahl 14
    • 35392  Giessen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/07/02
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Eur J Orthod. 2017 Jul 11. doi: 10.1093/ejo/cjx051
  •   Eur J Orthod. 2017 Dec 9. doi:10.1093/ejo/cjx091
  •   J Orofac Orthop 2018 Feb 20 doi.org/10.1007/s00056-018-0125-5
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.