Effect of Skeletally Anchored Herbst Appliance in Treatment of Skeletal Class 2 Due to Mandibular Retrusion

NCT04388046 | Completed DMC

• 1 other identifier: 107
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• dento-skeletal changes

  9 months

Study Arms (1)

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

Device: Herbst fixed functional appliance

Interventions

Herbst fixed functional appliance DEVICE

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.

skeletal class 2 malocclusion

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khaled ELHabbak: lead

Study Sites (1)

Faculty of Dental Medicine, Al- Azhar University, Cairo-boys.

Cairo, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• khaled El-Habbak

  Alazhar universty

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 14, 2020
• Study Start: December 25, 2017
• Primary Completion: January 2, 2019
• Study Completion: September 25, 2019
• Last Updated: May 14, 2020

Record last verified: 2020-05

Locations

EG (1)