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the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance

Primary Purpose

Class II Malocclusion

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Herbst Group
TFBC Group
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class II Malocclusion

Eligibility Criteria

18 Years - 20 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants will be selected based on the following inclusion criteria:

    1. Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°).
    2. Mandibular arch with minimum (up to 4mm) or no crowding.
    3. All permanent teeth are erupted (3rd molar not included).
    4. Good oral and general health.
    5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
    6. No previous orthodontic treatment.

Exclusion Criteria:

- 1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.

2. Patients with untreated decay or any endodontic lesions.

Sites / Locations

  • Nasr city

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Herbst Group

TFBC Group

Arm Description

• Group I: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (18-20y).

• Group II: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (18-20y).

Outcomes

Primary Outcome Measures

Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group
lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.

Secondary Outcome Measures

Amount of changes in dentoskeletal cephalometric measurements within each group separately
lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.

Full Information

First Posted
June 27, 2022
Last Updated
June 29, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05440526
Brief Title
the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance
Official Title
Efficacy of the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance in Young Adult Class II Orthodontic Patients; A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2020 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
April 15, 2022 (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 objective of the current study is to compare the dentofacial effects of the mini-plate anchored Herbst appliance Versus the dentally anchored Twin force bite corrector Appliance in Young Adult Class II Orthodontic Patients with retruded mandible.
Detailed Description
Study design: Prospective randomized clinical study. Study setting and population: This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study. Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion. Intervention: The orthodontic patients involved in this study will be treated by using fixed orthodontic appliances followed by one of two different types of fixed functional appliances; the type IV Herbst appliance (miniplate anchored appliance) and the Twin Force Bite Corrector (dentally anchored appliance). According to the type of the fixed functional appliance the patients will be randomly divided into two groups. The random allocation will be achieved by computer software: Group I: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (15-20y). Group II: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (15-20y). Records: The following diagnostic records will be taken for each patient before and after the fixed functional orthopedic treatment: Standardized study casts. Standardized extra-oral and intra-oral photographs. Lateral cephalometric and panoramic radiographs. Treatment steps: As for Group Ι: Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured leaving an extended part of the plate in the oral cavity which contain the soldered ball housing. The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint. Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally. When reactivation of the telescopic piston is needed, extension rings are used. As for Group ΙΙ: The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months. Finally follow finishing steps for each patient. Data management and analysis: The collected data will be tabulated statistically analyzed using Statistical Package for Social Sciences (SPSS, version 18, Inc, and Chicago, Ill).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herbst Group
Arm Type
Active Comparator
Arm Description
• Group I: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the type IV Herbst appliance (mini plate anchored appliance). The age of patients will be (18-20y).
Arm Title
TFBC Group
Arm Type
Active Comparator
Arm Description
• Group II: Include ten young adult orthodontic patients who are treated by using fixed orthodontic appliances followed by the Twin Force Bite Corrector appliance (dentally anchored appliance). The age of patients will be (18-20y).
Intervention Type
Procedure
Intervention Name(s)
Herbst Group
Intervention Description
Herbst Group: Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. The two mini plates are placed bilateral at the mandibular symphysis and fixed by at least 3 screws, the surgical wound is sutured. The surgical wound is left for 2 weeks for proper soft tissue healing, in the meantime separation in the arch, band placement on the first premolar and molar bilateral followed by impression for construction of the upper Herbst splint.
Intervention Type
Device
Intervention Name(s)
TFBC Group
Intervention Description
TFBC Group: The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months.
Primary Outcome Measure Information:
Title
Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group
Description
lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.
Time Frame
one year and four months
Secondary Outcome Measure Information:
Title
Amount of changes in dentoskeletal cephalometric measurements within each group separately
Description
lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.
Time Frame
one year and four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants will be selected based on the following inclusion criteria: Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°). Mandibular arch with minimum (up to 4mm) or no crowding. All permanent teeth are erupted (3rd molar not included). Good oral and general health. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement. No previous orthodontic treatment. Exclusion Criteria: - 1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment. 2. Patients with untreated decay or any endodontic lesions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud M. Fathy Aboelmahasen, PHD
Organizational Affiliation
Lecturer of orthodontics - Faculty of dental medicine - Al-Azhar university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nasr city
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance

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