Effect of Skeletally Anchored Herbst Appliance in Treatment of Skeletal Class 2 Due to Mandibular… (NCT04388046) | Clinical Trial Compass
CompletedNot Applicable
Effect of Skeletally Anchored Herbst Appliance in Treatment of Skeletal Class 2 Due to Mandibular Retrusion
Egypt10 participantsStarted 2017-12-25
Plain-language 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 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.
Who can participate
Age range
14 Years – 20 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
three dimensional evaluation of pharyngeal airway volume