NCT05913076

Class III Malocclusion and ALT-RAMEC

Evaluation of the Effects of Alternating Rapid Maxillary Expansion and Facemask Use in Cases of Class III Malocclusion Caused by Maxillary Retrognathia- A Prospective, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Trakya University · Academic / Other
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Face Mask
• Rapid Maxillary Expansion
• Maxillary Retrognathism

Interventions

Type	Name	Description
DEVICE	Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group	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.
DEVICE	Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group	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.
DEVICE	Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group	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.

Timeline

• Start date: 2012-01-13
• Primary completion: 2012-07-15
• Completion: 2012-08-15
• First posted: 2023-06-22
• Last updated: 2023-06-22

Locations

1 site across 1 country: Turkey (Türkiye)