Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-01-13
2012-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion
A sample of 40 patients, consisting of 18 males and 22 females with a mean age of 10.64 ± 0.98, who were in the growth and developmental stage, were divided into three treatment groups. The formation of groups was carried out with the aim of achieving a near-equal distribution of male and female participants within each group, as indicated in Table 1. The first group comprised 14 patients, while the second and third groups consisted of 13 patients each. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.
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.
Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion
The second group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.
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.
Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion
The third group comprised 13 patients who were in the growth and developmental stage. The skeletal age of the individual was determined through the acquisition of hand-wrist X-rays and the application of the Greulich and Pyle atlas at T1.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Skeletal Class III malocclusion (ANB ≤ -1°)
* Anterior cross-bite
* Class III molar relationship
* Horizontal growth pattern (SN/Go-Gn \< 30°)
Exclusion Criteria
* Systemic disorders
9 Years
11 Years
ALL
Yes
Sponsors
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Istanbul University
OTHER
Trakya University
OTHER
Responsible Party
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Hande Uzunçıbuk
Research Assistant Dr./ Principal Investigator
Principal Investigators
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Nilüfer Yılmaz Öğütlü, Dr.
Role: STUDY_DIRECTOR
Istanbul University
Gülsün Külekçi Çakan
Role: PRINCIPAL_INVESTIGATOR
Private Practitioner
Hülya Kılıçoğlu, Prof. Dr.
Role: STUDY_CHAIR
Istanbul University
Hande Uzunçıbuk, Dr.
Role: PRINCIPAL_INVESTIGATOR
Trakya University
Locations
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Trakya University
Edirne, , Turkey (Türkiye)
Countries
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Other Identifiers
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facemasktrakya1234
Identifier Type: -
Identifier Source: org_study_id
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