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

Assessment of the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One; A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion
• Intervention / Treatment: Device: Herbst Group; Device: TFBC Group

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 20 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: Group I
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; 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.; Other Names: Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison of condylar volume of Herbst group versus TFBC group	three dimensional automatic measurement of condylar volume as one unit by Romexis software	nine months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	nine months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Mahmoud Fathy, PHD, Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2020
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: July 16, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 603/307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No