the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance

NCT05440526 | Completed Phase 2 DMC

• 1 other identifier: 586/307
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

the objective of the current study is to compare the dentofacial effects of the mini-plate anchored Herbst appliance Versus the dentally anchored Twin force bite corrector Appliance in Young Adult Class II Orthodontic Patients with retruded mandible.

Conditions

Class II Malocclusion

Outcome Measures

Primary Outcomes (1)

• Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group

  lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.

  one year and four months

Secondary Outcomes (1)

• Amount of changes in dentoskeletal cephalometric measurements within each group separately

  one year and four months

Study Arms (2)

Herbst Group

ACTIVE COMPARATOR

• Group I: 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).

Procedure: Herbst Group

TFBC Group

ACTIVE COMPARATOR

• Group II: 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 PROCEDURE

Herbst 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. 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.

Herbst Group

TFBC Group DEVICE

TFBC 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.

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°).
• 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)

Nasr city

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

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

Study Officials

• Mahmoud M. Fathy Aboelmahasen, PHD

  Lecturer 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

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: September 10, 2020
• Primary Completion: March 8, 2022
• Study Completion: April 15, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)