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Skeletally Versus Dentally Anchored Herbst Appliance

Primary Purpose

Angle Class II, Division 1

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Herbst appliance
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle Class II, Division 1 focused on measuring Herbst, mini-plates, Skeletal Class 2 malocclusion

Eligibility Criteria

14 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Skeletal Class II malocclusion due to mandibular deficiency (SNA=82+4, ANB ≥4o).
  2. Overjet ≥5.0 mm.
  3. All permanent dentition erupted with exception of the third molars.
  4. 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:

  1. History of any medical problems that may interfere with orthodontic treatment.
  2. Previous orthodontic treatment.
  3. Clinical signs and symptoms of temporomandibular disorders.
  4. Bad oral hygiene.

Sites / Locations

  • AlAzharU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dentally anchored Herbst group

Skeletally anchored Herst group

Arm Description

Herbst appliance will be anchored on the mandibular dentition

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

Outcomes

Primary Outcome Measures

condylar volume changes
volumetric changes that affects the condylar head when comparing pre and post treatment
amount of mandibular advancement
increase in mandibular length

Secondary Outcome Measures

changes in inclination of lower anterior teeth
angular changes

Full Information

First Posted
January 29, 2018
Last Updated
May 22, 2020
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT04402164
Brief Title
Skeletally Versus Dentally Anchored Herbst Appliance
Official Title
Skeletally Versus Dentally Anchored Herbst Appliance During Treatment of Class 2 Mandibular Deficiency in Adolescent Patients; A CBCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Class II, Division 1
Keywords
Herbst, mini-plates, Skeletal Class 2 malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Dentally anchored Herbst appliance Group 2: Skeletally anchored Herbst appliance
Masking
Outcomes Assessor
Masking Description
another person than the investigators
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dentally anchored Herbst group
Arm Type
Active Comparator
Arm Description
Herbst appliance will be anchored on the mandibular dentition
Arm Title
Skeletally anchored Herst group
Arm Type
Active Comparator
Arm Description
Herbst appliance will be anchored on mini-plates placed in the para symphesial areas
Intervention Type
Device
Intervention Name(s)
Herbst appliance
Intervention Description
telescopic appliance for mandibular advancement
Primary Outcome Measure Information:
Title
condylar volume changes
Description
volumetric changes that affects the condylar head when comparing pre and post treatment
Time Frame
2 years
Title
amount of mandibular advancement
Description
increase in mandibular length
Time Frame
2 years
Secondary Outcome Measure Information:
Title
changes in inclination of lower anterior teeth
Description
angular changes
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al-Dany A. Mohamed, Prof
Organizational Affiliation
Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
AlAzharU
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Skeletally Versus Dentally Anchored Herbst Appliance

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