Class II Malocclusion, Division 1NCT04518865
Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods
A study testing Herbst appliance in people with Class II Malocclusion, Division 1, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion, Division 1
- What is being tested?
- Herbst appliance
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Apr 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 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Skeletal Class II malocclusion with retrognathic mandible (ANB >5°, SNB<76°)
- Normal growth pattern (SN/MP angle was in 25°- 35° range)
- Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
- Minimal or no crowding in the mandibular arch (0-5mm).
- Average inclination or slight retroclination of the lower incisor.
- An overjet greater than 5 mm.
Who cannot join
- Skletal Class I
- Craniofacial syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study
The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.
Read the detailed description
Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.
Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.
- Conditions
- Class II Malocclusion, Division 1
- Being tested
- Herbst appliance
- Keywords
- Class II malocclusion., prepubertal patients., postpubertal patients., Herbst appliance.
- Medical subject headings
- Malocclusion, Angle Class II, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbst applianceDevice
The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.
| Study group | Role | What they receive |
|---|---|---|
| pre-pubertal group. | Experimental | The patients were allocated into the pre-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS II and CVMS III Receives: Device: Herbst appliance |
| post-pubertal group | Experimental | The patients were allocated into the post-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS V and CVMS IV Receives: Device: Herbst appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal and dental changes
The DICOM (Digital Imaging and Communications in Medicine) files from the pre and post CBCT scans were imported to Mimics software (Version 10.1, Materialise NV, Leuven, Belgium); and the cephalometric landmarks and planes were defined . Linear sagittal measurements of point A, point B, glenoid fossa, upper incisor, lower incisor, upper molars, and lower molars were recorded in relation to orbital perpendicular plane.
Measured: 8 months
Secondary outcomes (1)
Condylar head position
The Most middle-superior point of the mandibular condyle was determined in sagittal, axial and coronal views. In the sagittal slice of the middle condylar head, a line was drowned through the widest measurement of the condylar heads visible on the slice, from this line, three lines were raised crossing the glenoid fossa at 45°, 90°, and 135° . Four linear measurements representing the anterosuperior, superior, posterosuperior, and posterior distance were taken from the glenoid fossa wall to the surface of the condyle
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Oct 2017
- Primary completion1 Feb 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Malocclusion, Division 1Studies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khaled farouk, Al-Azhar University
- Investigators
- khaled Farouk, lecturer, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518865
- Sponsor's protocol ID
- Herbst azhar
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 19 Aug 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study
- ClinicalTrials.gov ID
- NCT04518865
- Acronym / sponsor ID
- Herbst azhar
- Conditions
- Class II Malocclusion, Division 1
- Keywords
- Class II malocclusion., prepubertal patients., postpubertal patients., Herbst appliance.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Aug 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.
The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.
Detailed description
Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.
Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-pubertal group. | Experimental | Device: Herbst applianceThe patients were allocated into the pre-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS II and CVMS III |
| post-pubertal group | Experimental | Device: Herbst applianceThe patients were allocated into the post-pubertal group based on their skeletal stage of maturation using the modified cervical vertebrae maturation Staging (CVMS) with skeletal maturity stages of CVMS V and CVMS IV |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Skeletal Class II malocclusion with retrognathic mandible (ANB >5°, SNB<76°)
- Normal growth pattern (SN/MP angle was in 25°- 35° range)
- Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
- Minimal or no crowding in the mandibular arch (0-5mm).
- Average inclination or slight retroclination of the lower incisor.
Key exclusion criteria (2 listed)
- Skletal Class I
- Craniofacial syndrome.
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 applianceThe bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT. | Device | post-pubertal group, pre-pubertal group. |
Primary outcome
Skeletal and dental changes
Time frame: 8 months
The DICOM (Digital Imaging and Communications in Medicine) files from the pre and post CBCT scans were imported to Mimics software (Version 10.1, Materialise NV, Leuven, Belgium); and the cephalometric landmarks and planes were defined . Linear sagittal measurements of point A, point B, glenoid fossa, upper incisor, lower incisor, upper molars, and lower molars were recorded in relation to orbital perpendicular plane.
1 secondary outcome
Condylar head position
Time frame: 8 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 19 Aug 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 Farouk, lecturer principal investigator
Al-Azhar University
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 appliance in people with Class II Malocclusion, Division 1, run by Al-Azhar University 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 2 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 19 Aug 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?
Skeletal and dental changes (time frame: 8 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 19 Aug 2020.