Class III Malocclusion and ALT-RAMEC

NCT05913076 | Completed

• 1 other identifier: facemasktrakya1234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Face Mask; Rapid Maxillary Expansion; Maxillary Retrognathism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements

  6 months

Study Arms (3)

Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion

EXPERIMENTAL

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

Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion

EXPERIMENTAL

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

Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion

EXPERIMENTAL

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

Interventions

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

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

Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion

Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for second group 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

Investigation of the Effects of Alt-RAMEC and Facemask 3 week Use in Class III Malocclusion

Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group 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

Investigation of the Effects of Alt-RAMEC and Facemask 5 week Use in Class III Malocclusion

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Previous orthodontic treatment
• Systemic disorders

Sponsors & Collaborators

• Trakya University: lead
• Istanbul University: collaborator

Study Sites (1)

Trakya University

Edirne, 22000, Turkey (Türkiye)

Location

Study Officials

• Nilüfer Yılmaz Öğütlü, Dr.

  Istanbul University

  STUDY DIRECTOR

• Gülsün Külekçi Çakan

  Private Practitioner

  PRINCIPAL INVESTIGATOR

• Hülya Kılıçoğlu, Prof. Dr.

  Istanbul University

  STUDY CHAIR

• Hande Uzunçıbuk, Dr.

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Dr./ Principal Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 22, 2023
• Study Start: January 13, 2012
• Primary Completion: July 15, 2012
• Study Completion: August 15, 2012
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)