- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04402164
Skeletally Versus Dentally Anchored Herbst Appliance
Skeletally Versus Dentally Anchored Herbst Appliance During Treatment of Class 2 Mandibular Deficiency in Adolescent Patients; A CBCT Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- AlAzharU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- History of any medical problems that may interfere with orthodontic treatment.
- Previous orthodontic treatment.
- Clinical signs and symptoms of temporomandibular disorders.
- Bad oral hygiene.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dentally anchored Herbst group
Herbst appliance will be anchored on the mandibular dentition
|
telescopic appliance for mandibular advancement
|
Active Comparator: Skeletally anchored Herst group
Herbst appliance will be anchored on mini-plates placed in the para symphesial areas
|
telescopic appliance for mandibular advancement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
condylar volume changes
Time Frame: 2 years
|
volumetric changes that affects the condylar head when comparing pre and post treatment
|
2 years
|
amount of mandibular advancement
Time Frame: 2 years
|
increase in mandibular length
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes in inclination of lower anterior teeth
Time Frame: 2 years
|
angular changes
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Al-Dany A. Mohamed, Prof, Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AlAzharU-189
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Angle Class II, Division 1
-
Postgraduate Institute of Dental Sciences RohtakUnknownAngle Class II, Division 1 MalocclusionIndia
-
AL YousefKing Abdullah International Medical Research CenterUnknownMalocclusion, Angle Class I | Malocclusion; Angle Class II Division 1Saudi Arabia
-
Al-Azhar UniversityCompletedBimaxillary Protrusion | Angle Class II, Division 1 | Dental MalocclusionsEgypt
-
Ahmed Akram ElawadyCompletedBimaxillary Protrusion | Angle Class II, Division 1 | Dental MalocclusionsEgypt
-
Alexandria UniversityCompletedMalocclusion, Angle Class II, Division 1Egypt
-
Damascus UniversityCompletedMalocclusion, Angle Class II, Division 1Syrian Arab Republic
-
Ain Shams UniversityCompletedMalocclusion, Angle Class II, Division 1
-
FCI SystemTerminatedMalocclusion, Angle Class II, Division 1France
-
Damascus UniversityCompletedMalocclusion, Angle Class II, Division 1Syrian Arab Republic
-
Damascus UniversityCompletedMalocclusion, Angle Class II, Division 1Syrian Arab Republic
Clinical Trials on Herbst appliance
-
Izmir Katip Celebi UniversityCompletedMandibular Retrognathism
-
Al-Azhar UniversityCompletedClass II Malocclusion, Division 1Egypt
-
Klaus Barretto-LopesRecruitingMalocclusion, Angle Class IIBrazil
-
FCI SystemTerminatedMalocclusion, Angle Class II, Division 1France
-
Bernardo Quiroga SoukiUniversity of MichiganCompleted
-
The University of Hong KongCompleted
-
University Hospital, RouenCompletedObstructive Sleep ApneaFrance
-
Khaled ELHabbakCompletedMalocclusion, Angle Class IIEgypt
-
Hopital FochTerminatedObstructive Sleep ApneaFrance
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Academic Centre for Dentistry in AmsterdamUnknown