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

Class II Malocclusion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466344
• Other study ID #: 603/307
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 15, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 15, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

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.
• 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 ?? intra-oral elastics for both sides for 2 to 3 months. Finally follow finishing steps for each patient.

Locations

Country	Name	City	State
Egypt	Mahmoud Mohammad Fathy Abo - Elmahasen	Maadi	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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