ClinicalTrials.Veeva

Menu

Class III Malocclusion and ALT-RAMEC

T

Trakya University

Status

Completed

Conditions

Face Mask
Rapid Maxillary Expansion
Maxillary Retrognathism

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05913076
facemasktrakya1234

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

9 to 11 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

40 participants in 3 patient groups

Investigation of the Effects of Alt-RAMEC and Facemask 1 week Use in Class III Malocclusion
Experimental group
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.
Treatment:
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 group
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.
Treatment:
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 group
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.
Treatment:
Device: Delaire Face Mask (M0774-01, Leone S.p.A., Florence, Italy) for third group

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems