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the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One

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°). With agefrom 18 to 25 years.
    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

  • Mahmoud Mohammad Fathy Abo - Elmahasen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Herbst Group

TFBC Group

Arm Description

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).

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

comparison of condylar volume of Herbst group versus TFBC group
three dimensional automatic measurement of condylar volume as one unit by Romexis software

Secondary Outcome Measures

Measurement of of condylar volume within each group (Herbst group and TFBC group)
three dimensional automatic measurement of condylar volume as one unit by Romexis software

Full Information

First Posted
July 16, 2022
Last Updated
July 19, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05466344
Brief Title
the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One
Official Title
Assessment of the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One; A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
March 10, 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
This study will be directed to evaluate The effect of two different types of fixed functional appliances on the temporomandibular joint. 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
Detailed Description
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. outcomes measures: primary outcome: comparison of condylar volume of Herbst group versus TFBC group. secondary outcome: Measurement of of condylar volume within each group (Herbst group and TFBC group) 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. Observations: Changes in the condylar volume and changes in position of the condyle in relation to glenoid fossa as a result of remodeling process before and after the fixed functional orthopedic treatment at each group.

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
Model Description
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°). With agefrom 18 to 25 years. 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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herbst Group
Arm Type
Active Comparator
Arm Description
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
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
Device
Intervention Name(s)
Herbst Group
Other Intervention Name(s)
Group I
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TFBC Group
Other Intervention Name(s)
Group II
Intervention Description
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.
Primary Outcome Measure Information:
Title
comparison of condylar volume of Herbst group versus TFBC group
Description
three dimensional automatic measurement of condylar volume as one unit by Romexis software
Time Frame
nine months
Secondary Outcome Measure Information:
Title
Measurement of of condylar volume within each group (Herbst group and TFBC group)
Description
three dimensional automatic measurement of condylar volume as one unit by Romexis software
Time Frame
nine 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°). With agefrom 18 to 25 years. 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 Fathy, PHD
Organizational Affiliation
Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud Mohammad Fathy Abo - Elmahasen
City
Maadi
State/Province
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One

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