Class III Malocclusion and ALT-RAMEC

NACompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 13, 2012

Primary Completion Date

July 15, 2012

Study Completion Date

August 15, 2012

Conditions
Face MaskRapid Maxillary ExpansionMaxillary Retrognathism
Interventions
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."

Trial Locations (1)

22000

Trakya University, Edirne

All Listed Sponsors
collaborator

Istanbul University

OTHER

lead

Trakya University

OTHER

NCT05913076 - Class III Malocclusion and ALT-RAMEC | Biotech Hunter | Biotech Hunter