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

Not Applicable

• Conditions: Orthodontic Appliance Complication
• Interventions: Device: Extraoral protraction device; Device: Intraoral protraction device

• Registration Number: NCT05345756
• Lead Sponsor: Cairo University

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2022-03-26
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-19
• Last Update Submitted: 2022-04-19
• Study First Posted: 2022-04-26
• Last Update Posted: 2022-04-26
• Study Start: 2022-05-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extraoral Protraction Technique	Extraoral protraction device	using facemask for maxillary protraction after ALT-RAMEC protocol
Intraoral Protraction Technique	Intraoral protraction device	using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander

Primary Outcome Measures

Name	Time	Method
Maxillary skeletal changes	8 months	using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)

Secondary Outcome Measures

Name	Time	Method
Mandibular skeletal changes	8 months	using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB)
Maxillary and Mandibular dental changes	8 months	using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane)

Trial Locations

Locations (1)

Faculty of Oral and dental medicine - Cairo University; 🇪🇬 Cairo, Manial, Egypt