Condition category
Oral Health
Date applied
08/11/2018
Date assigned
06/12/2018
Last edited
06/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The position of the lower jaw can influence the position of the hyoid bone and the tongue, which can then affect the dimensions of the airway. Lower jaw advancement is a type of surgery that moves the jaw, and can change the dimensions of the airway. A Herbst appliance is a device that is attached inside the mouth to move the jaw. The jaw can be moved in a single step (maximum advancement) or in smaller, multiple steps (incremental advancement) using a Herbst appliance.
This study aims to look at the effects of maximum and incremental advancement using a Herbst appliance on airway dimensions and position of the hyoid bone in young adults with a retruded lower jaw.

Who can participate?
Patients aged 14-18 with mandibular retrognathia

What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive maximum advancement (MA), whereas the other will receive incremental advancement (IA). Both groups will receive mandibular advancement treatment using the Herbst-RPE appliance. The MA group will receive treatment for approximately 9-10 months. The IA group will receive treatment every 2 months until the treatment is complete.

What are the possible benefits and risks of participating?
The possible benefit of participating in this study is that patients will receive treatment more quickly, as they will not have to wait to be treated. There are no known risks to participants taking part in this study.

Where is the study run from?
Erciyes University, Faculty of Dentistry, Department of Orthodontics, Kayseri (Turkey)

When is the study starting and how long is it expected to run for?
November 2011 to September 2017

Who is funding the study?
This study does not require funding as all treatments are standard orthodontic treatments performed by Erciyes University

Who is the main contact?
Nisa Gul Amuk
nisagul@erciyes.edu.tr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nisa Gul Amuk

ORCID ID

http://orcid.org/0000-0002-3752-7100

Contact details

Erciyes Üniversitesi diş Hekimliği Fakültesi Ortodonti Anabilim Dalı
Kayseri
38039
Turkey
+905309237573
nisa.gul86@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2011/107

Study information

Scientific title

Changes in pharyngeal airway dimensions following incremental and maximum bite advancement during Herbst appliance therapy in young adult patients: a randomized prospective clinical study

Acronym

Study hypothesis

Null hypothesis:
There is no difference between maximum bite advancement and ıncremental advancement with Herbst appliance therapy on pharyngeal airway dimensions and hyoid bone position.

Ethics approval

Erciyes University Clinical Trials Ethical Committee, 06/12/2011, 2011/107

Study design

Interventional prospective single-center double-blinded randomised controlled parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Skeletal class II malocclusion with mandibular retrognathy

Intervention

Participants will be randomly allocated to receive either maximum advancement or incremental advancement in a 1:1 ratio using a random number table.
Both groups will receive mandibular advancement using the Herbst-RPE appliance with a stainless steel casted splint design.For the group receiving maximum advancement, advancement will be adjusted until a tet-a-tet incisor relation or super class I molar relationship is obtained. This will be completed for approximately 9-10 months. For the group receiving incremental advancement, a 2 mm shim will be inserted to the pivot ends of the plungers after a 4-5 mm initial forward movement of the mandible. For this group, advancement steps will continue every 2 months until a tet-a-tet incisor relation or super class I molar relationship is obtained.

Intervention type

Device

Phase

Drug names

Primary outcome measure

Changes in pharyngeal airway and hyoid position, assessed using lateral cephalometric radiography before using the Herbst-RPE appliance and immediately after appliance removal

Secondary outcome measures

Skeletal changes, assessed using lateral cephalometric radiography before using the Herbst-RPE appliance and immediately after appliance removal

Overall trial start date

28/11/2011

Overall trial end date

05/09/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Skeletal Class II malocclusion (ANB angle >4°) and mandibular retrognathy (SNB <78°)
2. Bilateral Class II molar and canine relationship (at least 3.5 mm)
3. Increased overjet (more than 7 mm)
4. Normal or decreased vertical dimensions (SN-GoGn ≤32)
5. Minimal crowding (≤4) and no missing teeth on upper and lower arches
6. Aged 14-18 years

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Craniofacial anomalies
2. Musculoskeletal diseases
3. Severe facial asymmetry
4. Severe maxillary transverse deficiency
5. Poor oral hygiene

Recruitment start date

01/10/2014

Recruitment end date

01/10/2015

Locations

Countries of recruitment

Turkey

Trial participating centre

Erciyes University, Faculty of Dentistry, Department of Orthodontics
Erciyes University, Faculty of Dentistry, Department of Orthodontics, Kayseri, Turkey
Kayseri
38039
Turkey

Sponsor information

Organisation

Erciyes University Clinical Trials Ethical Committee

Sponsor details

Erciyes Üniversitesi Merkez Kampüs Tıp Fakültesi Dekanlığı 38039 Talas Yolu Melikgazi/KAYSERİ
TURKEY
Melikgazi/Kayseri
38039
Turkey
+90 0 352 437 49 10 - 11
tipdekanlik@erciyes.edu.tr

Sponsor type

University/education

Website

Funders

Funder type

Not defined

Funder name

No funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We are intending publish this manuscript as original article in an peer-reviewed journal in June 2019

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

05/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes