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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05345756
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Intraoral protraction device
  • Device: Extraoral protraction device
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intraoral Protraction Technique

using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander

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
Active Comparator: Extraoral Protraction Technique

using facemask for maxillary protraction after ALT-RAMEC protocol

Device: Extraoral protraction device
Facemask which is an extraoral appliance used for maxillary protraction

Outcome Measures

Primary Outcome Measures

  1. Maxillary skeletal changes [8 months]

    using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)

Secondary Outcome Measures

  1. Mandibular skeletal changes [8 months]

    using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB)

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 13 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Oral and dental medicine - Cairo University Cairo Manial Egypt 11553

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Andrew Demian, BDS, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrew Wafdy Nan Demian, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05345756
Other Study ID Numbers:
  • ASR1
First Posted:
Apr 26, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 26, 2022