Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency

NCT03635463 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-08-05
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Conditions

Class II Division 1 Malocclusion

Outcome Measures

Primary Outcomes (1)

• enhancing mandibular skeletal growth

  it will be assessed by measuring the incremental growth by quick ceph (mm)

  9 months

Secondary Outcomes (3)

• dentoalveolar changes

  9 months

• Improvement of soft tissue profile

  9 months

• Patient's compliance

  9 months

Study Arms (2)

twin block appliance

EXPERIMENTAL

this group will receive conventional twin block appliance and followed up every month for 9 months.

Device: twin block appliance

modified twin block appliance group

EXPERIMENTAL

modified twin block appliance group , this group will receive the modified appliance and followed up every month for 9 months

Device: modified twin block appliance

Interventions

twin block appliance DEVICE

a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)

Also known as: mandibular functional appliance

twin block appliance

modified twin block appliance DEVICE

a convetional twin block functional appliance that enhances mandibular growth in growing patients

modified twin block appliance group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Skeletal Class II relationship (ANB \> 4°).
• Mandibular retrognathy (SNB \< 78°).
• Overjet ≥ 5 mm.
• Minimal crowding in dental arches (≤4 mm).
• Class II molar relation.
• Growing female patients.
• Patients with CMV3 maturation stage of the cervical verbrae.

You may not qualify if:

• No history of orthodontic treatment either prior to or during functional Appliance therapy.
• Posterior cross bites or severe maxillary transverse deficiency.
• Severe facial asymmetry determined by clinical or radiographical examination.
• Poor oral hygiene.
• Systemic diseases that may affect the orthodontic treatment results.
• Patients past their peak growth spurt.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: double blinded( participant and outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 3, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL