Class III Malocclusion and ALT-RAMEC

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

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

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

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

About this trial

This is an interventional treatment trial for Face Mask

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Trakya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

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

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

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05913076

First Posted

May 17, 2023

Last Updated

June 16, 2023

Sponsor

Trakya University

Collaborators

Istanbul University

1. Study Identification

Unique Protocol Identification Number

NCT05913076

Brief Title

Class III Malocclusion and ALT-RAMEC

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

January 13, 2012 (Actual)

Primary Completion Date

July 15, 2012 (Actual)

Study Completion Date

August 15, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Trakya University

Collaborators

Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Face Mask, Rapid Maxillary Expansion, Maxillary Retrognathism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

(Fabricated for every patient) Bonded-type Expansion Device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

(Fabricated for every patient) Bonded-type Expansion Device

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

(Fabricated for every patient) Bonded-type Expansion Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements

Description

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

Secondary Outcome Measure Information:

Title

Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nilüfer Yılmaz Öğütlü, Dr.

Organizational Affiliation

Istanbul University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gülsün Külekçi Çakan

Organizational Affiliation

Private Practitioner

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hülya Kılıçoğlu, Prof. Dr.

Organizational Affiliation

Istanbul University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Hande Uzunçıbuk, Dr.

Organizational Affiliation

Trakya University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Trakya University

City

Edirne

ZIP/Postal Code

22000

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

No

Face Mask, Rapid Maxillary Expansion, Maxillary Retrognathism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial