Evaluation of Skeletal and Dental Effect of the New Hybrid Aesthetic Functional Appliance

NCT ID: NCT06209125

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-05-08

Brief Summary

use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.

Detailed Description

The Sample:

The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

A sample size of 16 data pairs achieves 80.3% power to reject the null hypothesis of zero effect size when the population effect size is 1.00 and the significance level (alpha) is 0.050 using a two-sided paired t-test.

The ten patients will be selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Mansoura University.

The parents of each patient will be informed regarding the study and will sign written consent before starting the treatment.

Records:

1. Photographs:

1. Extra-oral (frontal -lateral -frontal with a smile).

2. Intra-oral (frontal -lateral - occlusal).

2. Radiographs:

1. Cephalometric.

2. Panorama.

3. Hand wrist radiographs.

3. Upper and lower orthodontic casts.

Appliance construction:

• After taking the upper and lower impressions; a construction wax bite will be done, and the mandible will be positioned anteriorly to achieve an edge-to-edge relationship parallel to the functional occlusal plane. Single-step advancement of the mandible will be achieved If the overjet ranges between (3-4 mm) or segmental advancement if it is larger than 5 mm using the Exactobite.
• HAF appliance will be constructed It is of double plate design, consisting of thermoplastic and acrylic parts The upper component is a vacuum-formed plate, made of transparent hard-elastic polyethylene sheet with 2 mm thickness, equipped with an acrylic advancement bar positioned in the anterior midpalatal region.

Similarly, the lower plate is constructed by thermoplastic material of the same width covering the six anterior teeth.

An acrylic guidance surface is placed over the plastic coverage on the lingual surfaces of lower incisors and canines, aimed to fit the upper bar.

Two-sided arms are extended from the acrylic resin body up to second molars adapted to the morphology of the lingual vestibule.

To obtain optimal shape matching of the opposing attachments, the working casts are mounted on a semi-adjustable articulator to contact in an end-to-end relationship.

Posterior teeth are intentionally exposed to facilitate eruption and leveling of a deep curve of Spee.

White-colored acrylic resin is used for the fabrication of acrylic parts to enhance esthetics.

Using a special plier, buttons are formed at the cervical third of upper and lower dental midlines to enable night-time wear of vertical elastics, or light-cured composite resin combined with appropriate transparent matrices can be used for button construction.

• The patients will be instructed to:

• use the HAF appliance for 12-14 hours per day.
• Maintain good oral hygiene, and brush your teeth after each meal.
• Attain an orthodontic clinic every three weeks.
• Use elastics at night.
• When the overjet is corrected; the upper part is served shortly as the anterior bite plane.

Conditions

Class II Malocclusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

use new device for treatment of class II malocclusion

Group Type: OTHER

hybrid aesthetic functional appliance

Intervention Type: DEVICE

treatment of class II division one malocclusion

Interventions

hybrid aesthetic functional appliance

treatment of class II division one malocclusion

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age included is the mixed dentition stage ( 6 -12 y )
• skeletal Class II division 1.
• Overjet more than 4 mm.

Exclusion Criteria

• Previous orthodontic treatment.
• Bad oral hygiene.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Sohaila Adnan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sohaila ad ahmed, master

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura University

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

IRB approval number

Identifier Type: OTHER

Identifier Source: secondary_id

sohaila

Identifier Type: -

Identifier Source: org_study_id