An interventional study of Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group and Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group in Face Mask, Rapid Maxillary Expansion and Maxillary Retrognathism, sponsored by Trakya University. Completed at 1 site in Turkey. Open to participants aged 9 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by Trakya University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 40 is above the median of 34 across 52 interventional studies indexed under Retrognathia.
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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.
Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for first group
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.
Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group
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.
Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third 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.
Also known as: (Fabricated for every patient) Bonded-type Expansion Device
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.
Also known as: (Fabricated for every patient) Bonded-type Expansion Device
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.
Also known as: (Fabricated for every patient) Bonded-type Expansion Device
Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements
Changes at the maxillary advancement, teeth positions and soft tissues amount were assessed in angular level. Skeletal measurements: Angular measurements: SNA (°), SNB (°), SN/S-Gn (Y-axis)(°), SN/Go-Gn (°), Ar-Go-Gn (°), SN/Go-Ar (°), and ANB (°) were measured. Dental measurements: Angular measurements: U1 to MaxP (°) for maxillary dentoalveolar measurements; L1-MandP (°) for mandibular dentoalveolar measurements; U1-L1 (°) for interdental measurements were performed. Soft tissue measurements: Changes at the upper and lower lip assessed. Angular measurements: G-Sn-Pg' (°), Nasolabial angle (°), and Labiomental angle (°) were measured.
Time frame: 6 months
Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements
Changes at the maxillary advancement, teeth positions and soft tissues amount were assessed in millimetrical level. Skeletal measurements: Millimetrical measurements: Co-A (mm) for maxillary skeletal measurement, Co-B (mm) for mandibular skeletal measurement, N-Me (mm), N-ANS (mm), and ANS-Me (mm) for maxillomandibular skeletal measurements were performed. Dental measurements: Millimetrical measurements: U1-MaxP (mm), U1-MaxVP (mm), U6-MaxP (mm), U6-MaxVP (mm) for maxillary dentoalveolar measurements; L1-MandP (mm), L1-MandVP (mm), L6-MandP (mm), L6-MandVP (mm) for mandibular dentoalveolar measurements; Overbite (mm) and overjet (mm) for interdental measurements were performed. Soft tissue measurements: Changes at the upper and lower lip assessed. Millimetrical measurements: Ls-S (mm) and Li-S (mm) were measured.
Time frame: 6 months
Plan to share: No
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