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

NCT05466344 | Completed Phase 2 DMC

• 1 other identifier: 603/307
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Class II Malocclusion

Outcome Measures

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

  nine months

Secondary Outcomes (1)

• Measurement of of condylar volume within each group (Herbst group and TFBC group)

  nine months

Study Arms (2)

Herbst Group

ACTIVE COMPARATOR

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

TFBC Group

ACTIVE COMPARATOR

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

Herbst Group DEVICE

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

Herbst Group

TFBC Group DEVICE

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

TFBC Group

Eligibility Criteria

• Age: 18 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mahmoud Mohammad Fathy Abo - Elmahasen

Maadi, Cairo Governorate, 11311, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mahmoud Fathy, PHD

  Clinical professor of orthodontics - Faculty of dental medicine - Al-Azhar university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor of orthodontics - Faculty of dental medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: July 20, 2022
• Study Start: June 15, 2020
• Primary Completion: March 10, 2022
• Study Completion: April 15, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)