Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients
ALT-RAMEC
1 other identifier
interventional
22
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedApril 26, 2022
April 1, 2022
7 months
March 26, 2022
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Maxillary skeletal changes
using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)
8 months
Secondary Outcomes (2)
Mandibular skeletal changes
8 months
Maxillary and Mandibular dental changes
8 months
Study Arms (2)
Intraoral Protraction Technique
EXPERIMENTALusing intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander
Extraoral Protraction Technique
ACTIVE COMPARATORusing facemask for maxillary protraction after ALT-RAMEC protocol
Interventions
Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol
Facemask which is an extraoral appliance used for maxillary protraction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Oral and dental medicine - Cairo University
Cairo, Manial, 11553, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Demian, BDS
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2022
First Posted
April 26, 2022
Study Start
May 1, 2022
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
April 26, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share