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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: Damascus University
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
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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