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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03635463
Other study ID # CEBD-CU-2018-08-05
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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