Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
12 December 2020 |
Main ID: |
NCT03251807 |
Date of registration:
|
13/08/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Effect of Low-Intensity Pulsed Ultrasound on Functional Treatment of Class II Malocclusion
|
Scientific title:
|
Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment of Class II Malocclusion: A Randomized Controlled Trial |
Date of first enrolment:
|
August 1, 2017 |
Target sample size:
|
40 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT03251807 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Syrian Arab Republic
| | | | | | | |
Contacts
|
Name:
|
Ghiath Mahmood, PhD. |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Angle class II malocclusion because of mandibular retrognathia
- O.J > 5 , SNB < 78
- Patient during growth spurt
Exclusion Criteria:
- TMJ disorders
- Poor oral hygiene
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Reason of contraindication of functional treatment
Age minimum:
11 Years
Age maximum:
14 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Malocclusion, Angle Class II
|
Intervention(s)
|
Other: LIPUS (Low-intensity pulsed ultrasound)
|
Device: Twin-block
|
Primary Outcome(s)
|
The duration of functional treatment
[Time Frame: After functional treatment which will take approximately 8 months]
|
Secondary Outcome(s)
|
Dentoskeletal effects of the functional treatment
[Time Frame: Changes will be evaluated before and after functional treatment which will take approximately 8 months]
|
Secondary ID(s)
|
UDDS-Ortho-06-2017
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|