Angle Class II, Division 1NCT04402164
Skeletally Versus Dentally Anchored Herbst Appliance
A study testing Herbst appliance in people with Angle Class II, Division 1, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The treatment of skeletal Class II malocclusion can be carried out through different approaches. One of these is the using of Fixed Functional Appliances (FFA), one of main drawbacks of these appliances is the proclination of the lower anterior teeth limiting the skeletal effect that is originally addressed in those… 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
- Angle Class II, Division 1
- What is being tested?
- Herbst appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 Jan 2020
- 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 Class II malocclusion due to mandibular deficiency (SNA=82+4, ANB ≥4o).
- Overjet ≥5.0 mm.
- All permanent dentition erupted with exception of the third molars.
- The patient should be at the maturity stage of MP3-I (where the fusion of the epiphysis and metaphysis is completed according to the developmental stage of the middle phalanx).
Who cannot join
- History of any medical problems that may interfere with orthodontic treatment.
- Previous orthodontic treatment.
- Clinical signs and symptoms of temporomandibular disorders.
- Bad oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skeletally Versus Dentally Anchored Herbst Appliance During Treatment of Class 2 Mandibular Deficiency in Adolescent Patients; A CBCT Study
The treatment of skeletal Class II malocclusion can be carried out through different approaches. One of these is the using of Fixed Functional Appliances (FFA), one of main drawbacks of these appliances is the proclination of the lower anterior teeth limiting the skeletal effect that is originally addressed in those patients.To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a more skeletal effect with retroclination of lower anterior teeth rather than their proclination. Although Herbst appliance is categorized as the best FFA with more stable skeletal and dentoalveolar effects, miniplates had never been tried as an anchorage source with Herbst appliance in skeletal Class II patients.
Read the detailed description
Skeletal Class II malocclusion is one of the most common orthodontic problems, which occurs in about one third of the population. Although there is many skeletal and dental combination that can contribute for the creation of Class II, however, mandibular retrusion is considered as the main contributing factor.
The treatment of skeletal Class II malocclusion can be carried out through three different time intervals. The first is an early treatment before the pubertal growth spurt through limiting the maxillary growth and stimulation of mandibular growth by using headgear and/or functional appliances. The second intervention would be during the maximum growth spurt through harnessing the spurt time to produce a more favorable skeletal effect by using of functional appliances either removable or fixed. Once growth had ceased, the third and last possible intervention would be one of the following treatment options; promoting the remaining growth through the usage of Fixed Functional Appliances (FFA), camouflage treatment and orthognathic surgery.
Fixed functional appliances (FFA) are aiming to stimulate mandibular growth by forward posturing the mandible to correct the skeletal antero-posterior discrepancy. Although there is always a controversy regarding the effectiveness of these appliances, many studies have been demonstrated successful correction of skeletal class II in adolescent patients through their use.
In a way to achieve this, it is recommended to use a rigid type of FFA like Herbst appliance and the Functional Mandibular Advancer rather than semi-rigid appliances like Forsus Fatigue Resistant Device (Forsus FRD).
Regardless of the patient's age, one of main drawbacks of these appliances is the proclination of the lower anterior teeth limiting the skeletal effect that is originally addressed in those patients.To overcome this limitation, mini screws had been used with both rigid and semi-rigid types of FFA. Incremental enhancement in the skeletal measurement has been noted by using them with the rigid type of FFA (e.g. Herbst appliance), however, the effect was still purely dentoalveolar when it came to semi rigid FFA (e.g. Forsus FRD), never to say that the success rate of these mini screws in the mandible is very low when compared with the maxilla which means a more complication and inconsistency in the clinical results.
To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a more skeletal effect with retroclination of lower anterior teeth rather than their proclination. Although Herbst appliance is categorized as the best FFA with more stable skeletal and dentoalveolar effects,miniplates had never been tried as an anchorage source with Herbst appliance.
- Conditions
- Angle Class II, Division 1
- Being tested
- Herbst appliance
- Keywords
- Herbst, mini-plates, Skeletal Class 2 malocclusion
- 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 applianceDevice
telescopic appliance for mandibular advancement
| Study group | Role | What they receive |
|---|---|---|
| Dentally anchored Herbst group | Active comparator | Herbst appliance will be anchored on the mandibular dentition Receives: Device: Herbst appliance |
| Skeletally anchored Herst group | Active comparator | Herbst appliance will be anchored on mini-plates placed in the para symphesial areas Receives: Device: Herbst appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
condylar volume changes
volumetric changes that affects the condylar head when comparing pre and post treatment
Measured: 2 years
amount of mandibular advancement
increase in mandibular length
Measured: 2 years
Secondary outcomes (1)
changes in inclination of lower anterior teeth
angular changes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start1 Mar 2018
- Primary completion1 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class II, 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Salam Mohamed, Al-Azhar University
- Investigators
- Al-Dany A. Mohamed, Prof, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402164
- Sponsor's protocol ID
- AlAzharU-189
- Status last verified
- May 2020
- First submitted
- 29 Jan 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletally Versus Dentally Anchored Herbst Appliance During Treatment of Class 2 Mandibular Deficiency in Adolescent Patients; A CBCT Study
- ClinicalTrials.gov ID
- NCT04402164
- Acronym / sponsor ID
- AlAzharU-189
- Conditions
- Angle Class II, Division 1
- Keywords
- Herbst, mini-plates, Skeletal Class 2 malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 26 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.
The treatment of skeletal Class II malocclusion can be carried out through different approaches. One of these is the using of Fixed Functional Appliances (FFA), one of main drawbacks of these appliances is the proclination of the lower anterior teeth limiting the skeletal effect that is originally addressed in those patients.To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a more skeletal effect with retroclination of lower anterior teeth rather than their proclination. Although Herbst appliance is categorized as the best FFA with more stable skeletal and dentoalveolar effects, miniplates had never been tried as an anchorage source with Herbst appliance in skeletal Class II patients.
Detailed description
Skeletal Class II malocclusion is one of the most common orthodontic problems, which occurs in about one third of the population. Although there is many skeletal and dental combination that can contribute for the creation of Class II, however, mandibular retrusion is considered as the main contributing factor.
The treatment of skeletal Class II malocclusion can be carried out through three different time intervals. The first is an early treatment before the pubertal growth spurt through limiting the maxillary growth and stimulation of mandibular growth by using headgear and/or functional appliances. The second intervention would be during the maximum growth spurt through harnessing the spurt time to produce a more favorable skeletal effect by using of functional appliances either removable or fixed. Once growth had ceased, the third and last possible intervention would be one of the following treatment options; promoting the remaining growth through the usage of Fixed Functional Appliances (FFA), camouflage treatment and orthognathic surgery.
Fixed functional appliances (FFA) are aiming to stimulate mandibular growth by forward posturing the mandible to correct the skeletal antero-posterior discrepancy. Although there is always a controversy regarding the effectiveness of these appliances, many studies have been demonstrated successful correction of skeletal class II in adolescent patients through their use.
In a way to achieve this, it is recommended to use a rigid type of FFA like Herbst appliance and the Functional Mandibular Advancer rather than semi-rigid appliances like Forsus Fatigue Resistant Device (Forsus FRD).
Regardless of the patient's age, one of main drawbacks of these appliances is the proclination of the lower anterior teeth limiting the skeletal effect that is originally addressed in those patients.To overcome this limitation, mini screws had been used with both rigid and semi-rigid types of FFA. Incremental enhancement in the skeletal measurement has been noted by using them with the rigid type of FFA (e.g. Herbst appliance), however, the effect was still purely dentoalveolar when it came to semi rigid FFA (e.g. Forsus FRD), never to say that the success rate of these mini screws in the mandible is very low when compared with the maxilla which means a more complication and inconsistency in the clinical results.
To overcome these limitations, miniplates anchored Forsus FRD were introduced, it showed high success rate in achieving a more skeletal effect with retroclination of lower anterior teeth rather than their proclination. Although Herbst appliance is categorized as the best FFA with more stable skeletal and dentoalveolar effects,miniplates had never been tried as an anchorage source with Herbst appliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance
| Arm | Type | Receives |
|---|---|---|
| Dentally anchored Herbst group | Active comparator | Device: Herbst applianceHerbst appliance will be anchored on the mandibular dentition |
| Skeletally anchored Herst group | Active comparator | Device: Herbst applianceHerbst appliance will be anchored on mini-plates placed in the para symphesial areas |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Skeletal Class II malocclusion due to mandibular deficiency (SNA=82+4, ANB ≥4o).
- Overjet ≥5.0 mm.
- All permanent dentition erupted with exception of the third molars.
- The patient should be at the maturity stage of MP3-I (where the fusion of the epiphysis and metaphysis is completed according to the developmental stage of the middle phalanx).
Key exclusion criteria (4 listed)
- History of any medical problems that may interfere with orthodontic treatment.
- Previous orthodontic treatment.
- Clinical signs and symptoms of temporomandibular disorders.
- 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 appliancetelescopic appliance for mandibular advancement | Device | Dentally anchored Herbst group, Skeletally anchored Herst group |
Primary outcome
condylar volume changes
Time frame: 2 years
volumetric changes that affects the condylar head when comparing pre and post treatment
amount of mandibular advancement
Time frame: 2 years
increase in mandibular length
1 secondary outcome
changes in inclination of lower anterior teeth
Time frame: 2 years
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 26 May 2020.
- Individual participant dataSharing planned: Undecided
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LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
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EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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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.
Al-Dany A. Mohamed, Prof study director
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 Angle Class II, 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 4 inclusion and 4 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 26 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?
condylar volume changes (time frame: 2 years). The study lists 2 primary outcomes in all. 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 26 May 2020.