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Completed

NCT Number: NCT05913076

Class III Malocclusion and ALT-RAMEC

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.

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Key information

Conditions

Face Mask Maxillary Retrognathism Rapid Maxillary Expansion

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University

Edirne, 22000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: (Fabricated for every patient) Bonded-type Expansion Device

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.

Other names: (Fabricated for every patient) Bonded-type Expansion Device

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.

Other names: (Fabricated for every patient) Bonded-type Expansion Device

Primary outcomes

  1. Evaluation of Skeletal, Dental, and Soft Tissue Angular Measurements

    Time frame: 6 months

    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 outcomes

  1. Evaluation of Skeletal, Dental, and Soft Tissue Millimetrical Measurements

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Istanbul University

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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