Clinical trial NCT05466344: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Class II Malocclusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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°). 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.
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: comparison of condylar volume of Herbst group versus TFBC group
timeFrame: nine months
Secondary outcomes:
measure: Measurement of of condylar volume within each group (Herbst group and TFBC group)
timeFrame: nine months
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Mahmoud Mohammad Fathy Abo - Elmahasen
state: Cairo
Study officials:
affiliation: Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university
name: Mahmoud Fathy, PHD
role: PRINCIPAL_INVESTIGATOR
References: