Effectiveness of Modified Functional Appliance With Expander

NCT06116500 | Unknown

• 1 other identifier: 664422
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial compares the effectiveness of a myofunctional appliance that uses a clear and modified twin block appliance with an expander made from 2mm biocompatible polyethylene terephthalate modified with Glycol thermoplastic material with a conventional twin block appliance with an expander. The trial will be conducted on adolescent patients with class II division 1.

Conditions

Class II Malocclusion

Keywords

twin block; thermoplastic material; clear expander,; adolescent; clinical trial

Outcome Measures

Primary Outcomes (2)

• Anteroposterior skeletal changes

  Skeletal changes using cephalometric radiographs including different angular measurements to estimate the changes between dental bases before and after treatment.

  T0 (before treatment), T1 (at end of the study) around 6-9 months

• Vertical skeletal changes

  Skeletal changes using cephalometric radiographs including different linear measurements to estimate the changes between dental bases before and after treatment.

  T0 (before treatment), T1 (at end of the study) around 6-9 months.

Secondary Outcomes (4)

• Soft tissue change

  T0 (before treatment), T1 (at end of the study) around 6-9 months

• Dentoalveolar changes

  T0 (before treatment), T1 (at end of the study) around 6-9 months

• Study model evaluation

  T0 (before treatment), T1 (at end of the study) around 6-9 months.

• Patient satisfaction from the appliance

  around 4 months.

Study Arms (2)

Modified twin block appliance with expander group

EXPERIMENTAL

For 24 patients with class II division malocclusion in their growing stages, using a 2 mm biocompatible and rigid PET-G thermoforming material to create two clear appliances for each patient. The material will be adapted separately on maxillary and mandibular casts using a pressure molding vacuum machine. Then, the appliances will be trimmed and finished and transferred to the articulator with the aid of a pre-existing working wax bite. The ramps will be made of cold cure acrylic on the thermoplastic sheets. Next, the expansion screw will be placed in the midline of the maxillary cast, and the maxillary appliance will be split midpalatally to fit the patient's individual needs.

Device: Modified twin block appliance with expander; Device: Conventional twin block appliance with expander

Conventional twin block appliance with expander group

EXPERIMENTAL

For 24 patients in a growing stage with class II division 1 malocclusion, these appliances will consist of removable maxillary and mandibular appliances. These will have a labial bow, Adam's clasps on the first molars, ball end clasps with incisal capping and expansion screw. The inclined bite blocks (ramps) will act as a guide to move the mandible forward.

Device: Modified twin block appliance with expander; Device: Conventional twin block appliance with expander

Interventions

Modified twin block appliance with expander DEVICE

These appliances are myofunctional appliance used for treating class II division growing adolescents.

Conventional twin block appliance with expander group; Modified twin block appliance with expander group

Conventional twin block appliance with expander DEVICE

These appliances are myofunctional appliances used for treating class II division growing adolescents.

Conventional twin block appliance with expander group; Modified twin block appliance with expander group

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients' age at the start of treatment: at growth spurt \[in stage 2 (Acceleration) - 3 (Transition) of cervical vertebral maturation\].
• Skeletal and dental relationships: skeletal class II with normal maxilla and retrognathic mandible. Moderate to severe dental class II division 1 malocclusion with overjet ≥ 8 mm.
• Horizontal/normal growth pattern.
• Convex profile with decreased or normal lower facial height (clinically and radiographically).
• Well-aligned/mild crowding of maxillary and mandibular dental arches.
• Good oral health free from caries and periodontal problems at the start of treatment.

You may not qualify if:

• Patients with vertical growth pattern or backward mandibular rotation tendency.
• Patients with open bite
• Patients with obvious facial asymmetry.
• Patients with orofacial clefting.
• Patients with bad oral habits.
• Active periodontal disease.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad, Collage of Dentistry

Baghdad, Al-Rusafa, Bab Al-moadham, 10011, Iraq

Location

Related Publications (1)

• Haik AA, Yassir YA. Efficiency of Polyethylene Terephthalate Glycol Thermoplastic Material to Functional and Expansion Forces in Orthodontic Applications: An Experimental Study. ScientificWorldJournal. 2025 Jan 10;2025:7232779. doi: 10.1155/tswj/7232779. eCollection 2025.

  PMID: 39840371 DERIVED

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

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

Study Officials

• Yassir A Yassir, Ph.D. (UK)

  Baghdad University, Collage of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the study, data collection and measurement will be conducted with the investigator. However, it won't be possible to blind the operator (investigator) due to the appliance design/shape difference, making the study single-blinded. Each patient will not know which type of twin block appliance will be used for them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The patients will be treated with twin block appliance

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: November 3, 2023
• Study Start: May 9, 2023
• Primary Completion: May 9, 2024
• Study Completion: June 9, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

IR (1)