Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients

Orthodontic Appliance Complication Clinical Trial

— ALT-RAMEC  

Official title:

Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345756
• Other study ID #: ASR1
• Status: Recruiting
• Phase: N/A
• 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
• 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

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