Class III Malocclusion and ALT-RAMEC
Condition: Face Mask; Rapid Maxillary Expansion; Maxillary Retrognathism
MeSH terms: Prognathism; Retrognathia; Malocclusion; Malocclusion, Angle Class III
Study type: Interventional

Summary: 
      Diverse viewpoints exist regarding the correlation between the conventional rapid maxillary
      expansion (RME) and facemask approach and the alternative RME and facemask hybrid technique
      (Alt-RAMEC) in terms of the degree of maxillary protraction. The findings of the study may
      offer a novel approach to protocol selection based on the anomaly's degree of severity. The
      objective of this investigation is to assess and contrast the skeletal and dentoalveolar
      outcomes of three distinct Alt-RAMEC techniques.
    

Detailed description: 
      Alternating rapid maxillary expansion and constriction (Alt-RAMEC) procedure is one of the
      most frequently used methods in the treatment of Class III cases caused by maxillary
      retrognathia. The objective of this investigation is to conduct a comparative analysis of the
      skeletal and dentofacial outcomes of three distinct techniques for maxillary protraction
      Following the primary recording, the patients were evaluated using bonded-type rapid
      maxillary expansion (RME) devices and three discrete Alt-RAMEC techniques (1, 3, and 5
      weeks). Lateral cephalograms were obtained from a sample of 40 patients (18 males and 22
      females) with a mean age of 10.64 ± 0.98. These images were taken both before (T1) and after
      the 6th month of facemask treatment (T2), and were subjected to total and local
      superimpositions. The Wilcoxon Sign, Kruskal-Wallis and Mann-Whitney U tests were used to
      evaluate the data.
    

Intervention name(s): Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group; Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group; Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group
Intervention type(s): Device; Device; Device
Intervention description(s): The study involved the fabrication of occlusal-coverage bonded type RME devices utilizing Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy). Each patient in Group 1 (classical RME method) was instructed to open Hyrax screw twice a day for a week. At the end of the respective periods (1 week), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.; The same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 2. Each patient in Group 2 (3-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. At the end of the respective periods (3 weeks), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.; The same fabrication of occlusal-coverage bonded type RME devices were utilized Hyrax screws (A0620-11, Leone S.p.A., Firenze, Italy) in Group 3. Each patient in Group 3 (5-week Alt-RAMEC protocol), the patients were instructed to activate Hyrax screw twice a day for one week, close the screw for following week, and open the screw over the third week. The aforementioned screw open-close procedure was implemented over a period of five weeks. At the end of the respective periods (5 weeks), the screws were fixed with ligatures, and the patients were evaluated.
Face-mask treatment was subsequently started after RME. Totaling 700 g of extraoral traction force applied to maxilla. Patients were advised to wear Delaire type facemasks (M0774-00, Leone SpA) 14-16 hours a day for 6 months.
Other intervention name(s): (Fabricated for every patient) Bonded-type Expansion Device; (Fabricated for every patient) Bonded-type Expansion Device; (Fabricated for every patient) Bonded-type Expansion Device
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment