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CompletedNCT05466344Updated Jul 21, 2022

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

A Phase 2/3 interventional study of Herbst Group and TFBC Group in Class II Malocclusion, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Al-Azhar University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Jun 2020, registered Jul 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 20 Years
Sex
All
01

Study 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

Read the detailed description

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.

outcomes measures:

  1. primary outcome: comparison of condylar volume of Herbst group versus TFBC group.
  2. secondary outcome: Measurement of of condylar volume within each group (Herbst group and TFBC group)

Treatment steps:

As for Group Ι:

  1. Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance.
  2. 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.
  3. 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.
  4. Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally.
  5. When reactivation of the telescopic piston is needed, extension rings are used.

As for Group ΙΙ:

  1. The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment.
  2. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches.
  3. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months.
  4. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months.
  5. 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.

02

Conditions studied

  • Class II Malocclusion
03

In context

Malocclusion

457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.

This study's enrollment of 20 is below the median of 36 across 372 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 506 studies on the registry; 168 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

    1. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
  1. Patients with untreated decay or any endodontic lesions.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Herbst Group

    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).

    Device: Herbst Group

  • Active comparator
    TFBC Group

    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).

    Device: TFBC Group

Interventions

  • DeviceHerbst Group

    1. Two mini plates are chosen, the last hole in every plate is used to solder the ball housing of type IV Herbst appliance. 2. 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. 3. 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. 4. Cementation of upper Herbst splint with connecting the telescopic piston through fitting of the plunger into the tube bilaterally. 5. When reactivation of the telescopic piston is needed, extension rings are used.

    Also known as: Group I

  • DeviceTFBC Group

    1. The patients will be treated by fixed orthodontic appliance with using series of orthodontic NiTi arch wires for levelling and alignment. 2. Installation of series of orthodontic stainless steel arch wires until 0.0019 x 0.0025 inch for both arches. 3. Installation of the Twin Force Bite Corrector appliance for 4 to 6 months. 4. Using of class ΙΙ intra-oral elastics for both sides for 2 to 3 months. 5. Finally follow finishing steps for each patient.

    Also known as: Group II

06

What researchers measure

Primary outcomes

  1. comparison of condylar volume of Herbst group versus TFBC group

    three dimensional automatic measurement of condylar volume as one unit by Romexis software

    Time frame: nine months

Secondary outcomes

  1. 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

    Time frame: nine months

07

Study locations

1 site
  • Mahmoud Mohammad Fathy Abo - Elmahasen
    Maadi, Cairo 11311, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05466344
Lead sponsor
Al-Azhar University
Responsible party
Mahmoud M. Fathy Aboelmahasen (Clinical professor of orthodontics - Faculty of dental medicine, Al-Azhar University) — Principal investigator
First posted
Jul 20, 2022
Start date
Jun 15, 2020
Primary completion
Mar 10, 2022
Completion
Apr 15, 2022
Last update
Jul 21, 2022

Study contacts

Mahmoud Fathy, PHD
principal investigator · Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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