Effects of the Herbst Appliance With Different Anchorages and Twin-Block Appliance in Class II Malocclusion

NCT02411812 | Active Not Recruiting

• 1 other identifier: HASA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Herbst appliance with indirect skeletal anchorage in mini-implants is capable of preventing excessive inclination of the lower incisors at the end of the treatment when compared to the Herbst appliance with dental anchorage and Twin-Block appliances in patients with Class II malocclusion and overjet ≥ 6 mm.

Conditions

Malocclusion, Angle Class II

Keywords

Orthodontic Appliances, Functional; Herbst Appliance; Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (1)

• Lower incisors position changes as measured by tomographic superimposition of the mandible.

  Comparison in lower incisors position between the two groups at the end of the treatment.

  12 months

Secondary Outcomes (7)

• Morphological mandible changes as measured by tomographic superimposition of the cranial base.

  12 months

• Maxilla changes as measured by tomographic superimposition of the cranial base.

  12 months

• Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.

  12 months

• Lower molar position changes as measured by tomographic superimposition of the mandible.

  12 months

• Upper molar position changes as measured by tomographic superimposition of the maxilla.

  12 months

Study Arms (3)

Herbst appliance with skeletal anchorage

EXPERIMENTAL

Group treated with the Herbst appliance with indirect skeletal anchorage in mini-implants.

Device: Herbst appliance with skeletal anchorage

Herbst appliance with dental anchorage

ACTIVE COMPARATOR

Group treated with the conventional Herbst appliance with dental anchorage.

Device: Herbst appliance with dental anchorage

Twin-Block appliances

ACTIVE COMPARATOR

Group treated with Twin-Block appliance.

Device: Twin-Block appliance

Interventions

Herbst appliance with skeletal anchorage DEVICE

Group treated with the Herbst appliance with indirect skeletal anchorage in mini-implants.

Herbst appliance with skeletal anchorage

Herbst appliance with dental anchorage DEVICE

Group treated with the conventional Herbst appliance with dental anchorage.

Herbst appliance with dental anchorage

Twin-Block appliance DEVICE

Group treated with Twin-Block appliance

Twin-Block appliances

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Teenagers aged from 10 to 14 years old (both genders)
• Parental permission with a signed consent form
• Referral from the Orthodontics Clinic of the State of Rio de Janeiro University or private clinics
• Presenting Class II, Division 1 malocclusion with convex profile and minimum overjet of 6 mm in permanent dentition.

You may not qualify if:

• Missing teeth.

Sponsors & Collaborators

• Klaus Barretto-Lopes: lead

Study Sites (1)

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Location

Related Publications (26)

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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

• Klaus B Lopes, PhD

  Rio de Janeiro State University

  PRINCIPAL INVESTIGATOR

• Kevin D O'Brien, PhD

  University of Manchester

  STUDY DIRECTOR

• José Augusto M Miguel, PhD

  Rio de Janeiro State University

  STUDY CHAIR

• Nathália Palomares, MSc

  Rio de Janeiro State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor in Orthodontics

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 8, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

BR (1)