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

Class II Division 1 Malocclusion Clinical Trial

Official title:

Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03635463
• Other study ID #: CEBD-CU-2018-08-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Skeletal Class II relationship (ANB > 4°).

2. Mandibular retrognathy (SNB < 78°).

3. Overjet = 5 mm.

4. Minimal crowding in dental arches (=4 mm).

5. Class II molar relation.

6. Growing female patients.

7. Patients with CMV3 maturation stage of the cervical verbrae.

Exclusion Criteria:

1. No history of orthodontic treatment either prior to or during functional Appliance therapy.

2. Posterior cross bites or severe maxillary transverse deficiency.

3. Severe facial asymmetry determined by clinical or radiographical examination.

4. Poor oral hygiene.

5. Systemic diseases that may affect the orthodontic treatment results.

6. Patients past their peak growth spurt.

Related Conditions & MeSH terms

• Class II Division 1 Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• twin block appliance
a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)
• modified twin block appliance
a convetional twin block functional appliance that enhances mandibular growth in growing patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	enhancing mandibular skeletal growth	it will be assessed by measuring the incremental growth by quick ceph (mm)	9 months
Secondary	dentoalveolar changes	quick ceph (mm)	9 months
Secondary	Improvement of soft tissue profile	quick ceph (mm)	9 months
Secondary	Patient's compliance	table chart (no of hours/day)	9 months