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Malocclusion, Angle Class IINCT04388046

Effect of Skeletally Anchored Herbst Appliance in Treatment of Skeletal Class 2 Due to Mandibular Retrusion

A study testing Herbst fixed functional appliance in people with Malocclusion, Angle Class II, run by Khaled ELHabbak at 1 site in Egypt.

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

Ten adolescent female patients with Class 2 mandibular deficiency with a mean age of 16.5 ±1.71 years treated with type IV Herbst appliance. Skeletally anchored appliance was connected directly to the mandible by a bilateral reconstruction bone plates to provide a skeletal anchorage, while connected to the maxilla… Read more about this study

Who is it for?
Ages 14 to 20 years, women onlyHealthy volunteers can take part
Conditions the study is for
Malocclusion, Angle Class II
What is being tested?
Herbst fixed functional appliance
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteEgypt
Study dates
25 Dec 2017to 25 Sep 2019
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 14 to 20 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Skeletal and dental Class II malocclusion due to mandibular retrusion (SNB≤ 76° )
  • Overjet ≥ 5.0 mm
  • Normal or low FMA angle (≤ 28)
  • Complete permanent dentition, excluding the third molars
  • Minimum or no crowding in the mandibular arch
  • All the patient involved in the study will be in stages 5 and 6 based on the modified cervical vertebral maturation stages (CVMS).

Who cannot join

  • History of any medical problems that may interfere with orthodontic treatment
  • Previous orthodontic treatment.
  • Clinical signs and symptoms of temporomandibular disorders.
  • Mandibular asymmetries.
  • Bad oral hygiene.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dental Medicine, Al- Azhar University, Cairo-boys.

    Cairo

Other trials in Egypt

About this study

Official title: Three-dimensional Evaluation of Pharyngeal Airway Measurements Following Class 2 Correction With Skeletally Anchored Herbst Appliance

Ten adolescent female patients with Class 2 mandibular deficiency with a mean age of 16.5 ±1.71 years treated with type IV Herbst appliance.

Skeletally anchored appliance was connected directly to the mandible by a bilateral reconstruction bone plates to provide a skeletal anchorage, while connected to the maxilla through dental splint connecting upper canine, first premolar, first and second molars through the use of orthodontic bands connected together palatally by a heavy 1mm stainless steel wire.

The treatment duration was 9 months, then the appliances were removed,The Cone Beam Computed Tomography (CBCT) scans were taken before and immediately after Herbst treatment to analyse airway volume, also 3D measurement of the effective mandibular length has been taken. Cephalometric film was extracted from CBCT scans and analysed for dentoskeletal and soft tissue changes.

Read the detailed description

The Herbst appliance was anchored by two reconstruction plates located bilaterally in the mandible between the canine and first premolar, while attached to the maxilla through dental splints utilizing orthodontic bands.

For each patient, two reconstruction plates were sent to the laboratory for LASER welding of the Herbst bases to the first hole of each reconstruction plate. This assembly was projected transmucosal and exposed into the oral cavity for direct connection with the Herbst appliance.

3D model for the mandible of each patient was printed with 3D printer machine after extracted from the patient CBCT.

The reconstruction plates were bended using a 3-jaw contouring and bending plier to be adapted to the printed model on the predetermined location between mandibular canine and 1st premolar bilaterally.Sterilization of the reconstruction plates were then preformed.

For surgical placement of reconstruction plates, An envelope flap with one releasing incision (three-corner flap)was made starting with the horizontal incision 3-mm apical to the gingival crest from the mesial surface of lower second premolar to the distal surface of lower lateral incisor on one side, then a vertical incision was made at the mesial end of the horizontal incision, extending apically to the chin level to allow unstrained placement of the reconstruction plate. The same procedures were performed on the other side.

Reconstruction plates were checked for proper positioning before fixation, the reconstruction plate was held in place, a small hole, only through the cortex of bone, was made by a surgical round bur through the middle hole of the reconstruction plate. This was followed by complete drilling using a surgical screw drill , a 2.3mm screw was used to fix the reconstruction plate in its place using the corresponding screwdriver .

Consequently, drilling of the upper and lower holes and fixation of screws were performed in the same manner, the same steps were performed to fix the contralateral reconstruction plate in its place.

The flaps were repositioned and sutured with 3/0 silk suture. Proper size readymade bands were selected for the maxillary first premolars, first and second molars, while canine bands were custom made specifically for each patient,The bands were accurately fitted in their place and an alginate impression for upper jaw was taken, washed and disinfected, then the bands were reinserted into the alginate impression and the impression was poured in white orthodontic stone. Then the cast was sent to the laboratory for constructing the palatal connecting wire and laser-welding the bands to the palatal wires. At this time, the bases of the telescopic mechanism were welded to the buccal surface of maxillary 1st molar bands.

In most patients, the mandible was advanced to an incisal edge-to-edge position in one step advancement, however, in two patients, because of the large overjet, the edge to edge position seemed to be traumatic, therefore two steps advancement about 5 mm each was undertaken using suitable spacers.

After adjustment and try in of all assembly, the maxillary splint was then cemented using glass ionomer cement .

The coupling heads of telescopic rods and tubes were secured inside the appliance bases on reconstruction plate and maxillary 1st molar bands respectively with the C-clip using plier.

Patients were recalled one day following appliance insertion then every two weeks.

The appliances were removed after nine months, the remnants of the glass ionomer cement were eliminated using finishing bur and teeth were polished using fluoride pumice powder with a rubber polishing cup in a low-speed hand piece. The reconstruction plates were removed with a second surgery.

Completion of orthodontic treatment for each patient was performed with fixed appliance to reach firm and functioning stable occlusion.

The images were acquired using CBCT machine. A scout view was obtained, and adjustments were made to ensure that all patients were correctly aligned in the scanner according to adjustment light beam before acquisition.

After acquisition, data were exported and transferred in digital imaging and communication in medicine (DICOM) format and downloaded via a CD to a personal computer for Airway volume calculation and extraction of both panoramic and lateral cephalometric radiograph using a specific software.

Serial steps were followed by the same investigator to standardize the measurements in all scans. An identification number was assigned to each CBCT image prior to measurement in order to mask the patient's name and the time point during CBCT analysis. The CBCT images were re-matched to the patient's name after data collection were completed.

The CBCT scans were taken before and immediately after Herbst treatment to analyze the following….

  • 3D volumetric air way analysis.
  • 3D measurement of the effective mandibular length.
  • Cephalometric analysis after extraction from the CBCT. To ensure accurate and repeatable measures of all patients, all CBCT scans had to be oriented by the software before taking the measures.
Being tested
Herbst fixed functional appliance
Medical subject headings
Malocclusion, Angle Class II

What participants receive

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

  • Herbst fixed functional applianceDevice

    Herbst appliance could be considered as an artificial joint working between maxilla and mandible. The appliance consists of a bilateral telescope mechanism attached to upper and lower jaws keeping the mandible in an anterior jumped position.

Study groups in NCT04388046
Study groupRoleWhat they receive
skeletal class 2 malocclusionExperimental10 patients treated with type IV Herbst appliance. The appliance was connected directly to the mandible by a bilateral reconstruction bone plates to provide a skeletal anchorage and avoid any mandibular teeth involvement
Receives: Device: Herbst fixed functional appliance

What is being measured

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

  1. three dimensional evaluation of pharyngeal airway volume

    The air way analysis option was chosen to start the measurement. The nasopharynx, velopharynx, glossopharyngeal and the total air way horizontal boundaries all had been set parallel to Frankfort horizontal The vertical anterior boundary of pharyngeal airway was represented by the line perpendicular to FH plane and tangent to PNS.

    A quick method for determining the airway sensitivity has been chosen using a threshold value of 70 unit which was find optimum for airway segmentation.

    Consequently, the software was automatically converted the segmented airway into 3D volume.

    The 3D air way volume for the nasopharynx, velopharynx and glossopharyngeal as well as the total pharyngeal airway were calculated and tabulated.

    Measured: 9 months

Secondary outcomes (1)
  1. dento-skeletal changes

    A constructed lateral cephalometric image was constructed from the patient's CBCT for assessment of maxillary and mandibular bony changes as well as the upper and lower anterior teeth.

    Measured: 9 months

Timeline

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

  1. First posted14 May 2020
  2. Study start25 Dec 2017
  3. Primary completion2 Jan 2019
  4. Study completion25 Sep 2019

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388046
Sponsor's protocol ID
107
Status last verified
May 2020
First submitted
8 May 2020
Last updated
14 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Herbst fixed functional appliance in people with Malocclusion, Angle Class II, run by Khaled ELHabbak at 1 site in Egypt.

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 6 inclusion and 5 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 14 May 2020. 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 Egypt. 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?

three dimensional evaluation of pharyngeal airway volume (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 May 2020.

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