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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05345756
Other study ID # ASR1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date January 1, 2023

Study information

Verified date April 2022
Source Cairo University
Contact Andrew Demian, BDS
Phone +0201272912299
Email androwafdy@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction


Description:

Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date January 1, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 13 Years
Eligibility Inclusion Criteria: - Male or Female Growing Patient ( CVM2-CVM3 ) - Skeletal class III (ANB = 0 , A-NV= -2 and wits appraisal < -0.3mm) - Erupted upper and lower first permanent molars and permanent incisors - Reverse overjet up to -4 mm Exclusion Criteria: - History of previous orthodontic treatment - Cleft lip/palate patients - Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting). - Patients with syndromes

Study Design


Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

Device:
Intraoral protraction device
Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol
Extraoral protraction device
Facemask which is an extraoral appliance used for maxillary protraction

Locations

Country Name City State
Egypt Faculty of Oral and dental medicine - Cairo University Cairo Manial

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maxillary skeletal changes using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA) 8 months
Secondary Mandibular skeletal changes using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB) 8 months
Secondary Maxillary and Mandibular dental changes using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane) 8 months
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