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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- Malocclusion, Angle Class II
- 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 group | Role | What they receive |
|---|---|---|
| skeletal class 2 malocclusion | Experimental | 10 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.
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)
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.
- First posted14 May 2020
- Study start25 Dec 2017
- Primary completion2 Jan 2019
- Study completion25 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Khaled ELHabbak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khaled ELHabbak, Al-Azhar University
- Investigators
- khaled El-Habbak, Principal investigator, Alazhar universty
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Evaluation of Pharyngeal Airway Measurements Following Class 2 Correction With Skeletally Anchored Herbst Appliance
- ClinicalTrials.gov ID
- NCT04388046
- Acronym / sponsor ID
- 107
- Conditions
- Malocclusion, Angle Class II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Khaled ELHabbakUniversity, hospital or other
- Study start
- 25 Dec 2017 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skeletal class 2 malocclusion | Experimental | Device: Herbst fixed functional appliance10 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 |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbst fixed functional applianceHerbst 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. | Device | skeletal class 2 malocclusion |
Primary outcome
three dimensional evaluation of pharyngeal airway volume
Time frame: 9 months
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.
1 secondary outcome
dento-skeletal changes
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
khaled El-Habbak principal investigator
Alazhar universty
1 site in 1 country: see every site and its status.
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.