Class III Malocclusion and ALT-RAMEC

Face Mask Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05913076
• Other study ID #: facemasktrakya1234
• Status: Completed
• Phase: N/A
• Start date: January 13, 2012
• Est. completion date: August 15, 2012

Study information

• Verified date: June 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2012
• Est. primary completion date: July 15, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

Inclusion Criteria:

• Maxillary retrognathia (SNA = 79°)
• Skeletal Class III malocclusion (ANB = -1°)
• Anterior cross-bite
• Class III molar relationship
• Horizontal growth pattern (SN/Go-Gn < 30°)

Exclusion Criteria:

• Previous orthodontic treatment
• Systemic disorders

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class III
• Maxillary Retrognathism
• Prognathism
• Rapid Maxillary Expansion
• Retrognathia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (2)

Lead Sponsor	Collaborator
Trakya University	Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	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.	6 months