Skeletally Versus Dentally Anchored Herbst Appliance

NCT04402164 | Completed DMC

• 1 other identifier: AlAzharU-189
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Angle Class II, Division 1

Keywords

Herbst, mini-plates, Skeletal Class 2 malocclusion

Outcome Measures

Primary Outcomes (2)

• condylar volume changes

  volumetric changes that affects the condylar head when comparing pre and post treatment

  2 years

• amount of mandibular advancement

  increase in mandibular length

  2 years

Secondary Outcomes (1)

• changes in inclination of lower anterior teeth

  2 years

Study Arms (2)

Dentally anchored Herbst group

ACTIVE COMPARATOR

Herbst appliance will be anchored on the mandibular dentition

Device: Herbst appliance

Skeletally anchored Herst group

ACTIVE COMPARATOR

Herbst appliance will be anchored on mini-plates placed in the para symphesial areas

Device: Herbst appliance

Interventions

Herbst appliance DEVICE

telescopic appliance for mandibular advancement

Dentally anchored Herbst group; Skeletally anchored Herst group

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 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).

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.
• Bad oral hygiene.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

AlAzharU

Cairo, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Orthodontic Appliances, Functional

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Al-Dany A. Mohamed, Prof

  Al-Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: another person than the investigators
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontist

Model Details: Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: May 26, 2020
• Study Start: March 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Locations

EG (1)