NCT06486324

Brief Summary

The aim of this clinical trial was to determine the efficacy of a locked modified bonded acrylic rapid maxillary expansion appliance, also known as an asymmetric rapid maxillary expansion appliance (ARME), in patients with a true unilateral posterior crossbite resulting from transversal maxillary deficiency in the mixed dentition.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
14.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

June 18, 2024

Last Update Submit

June 30, 2024

Conditions

Keywords

True unilateral posterior crossbiteAsymmetric maxillary expansionMixed dentition

Outcome Measures

Primary Outcomes (5)

  • Widths of skeletal structures

    The widths of the nasal cavity, maxilla and mandible were measured in millimetres on the frontal radiographs and these widths were also determined separately on both the crossbite and non-crossbite sides.This involved marking anatomical points (lateral piriform rim,jugale, gonial notch and Lo points on both sides of the face and crista galli, a single point) and drawing two reference lines.The horizontal reference line was drawn by connecting the Lo points on both sides.The perpendicular line drawn from the crista galli to the horizontal reference line was the midsagittal line, which divided the face into two separate halves.The distances between the inter lateral piriform points, the inter jugular points and the inter gonial points corresponded to the width of the nasal cavity, the maxillary width and the mandibular width, respectively.The distances between the anatomical points on one half of the face to the midsagittal line indicated the skeletal width on that side.

    Before expansion (T1),through expansion completion,an average 1 month (T2),and through retention completion, an average 3 months (T3)

  • Skeletal maxillomandibular width ratios

    The skeletal maxillomandibular ratio was calculated by dividing the skeletal maxillary width by the skeletal mandibular width and multiplying the result by 100. This percentage was calculated separately for the crossbite and non-crossbite sides and also for the total maxillary and mandibular width.

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Inclinations of upper and lower first molars

    The angle formed by the intersection of the horizontal reference line with the line indicating the axis of a molar tooth defines the angular inclination of the molar tooth. The line indicating the axis of a molar was defined by the line connecting the crest of the buccal tubercle of the tooth and the most external part of the buccal curvature of the crown on the frontal radiograph. The angular inclinations of the upper and lower first molars were measured in degrees on frontal radiographs.

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Amount of movement of deciduous canines and first molars in the transversal plane on the crossbite and non-crossbite sides.

    The perpendicular distances of deciduous canines and permanent first molars on the crossbite and non-crossbite sides to the median plane (MP), which was established as the reference plane on the dental cast. Distance measurements of the teeth were made in millimeter and these measurements represent the amount of movement of the canines and molars in the transverse plane.

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Intercanine and intermolar distance on dental cast

    The distance measurement between the deciduous canines in the transversal plane on the upper and lower dental casts (intercanine distance). The distance measurement between the permanent first molars in the transversal plane on the upper and lower dental casts (intermolar distance). Distance measurements of the teeth were made in millimeter.

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

Secondary Outcomes (6)

  • Position of the maxilla in the sagittal and vertical plane on lateral cephalometric radiography

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Position of the mandibula in the sagittal and vertical plane on lateral cephalometric radiograph

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Maxillomandibular relationship in the sagittal plane on lateral cephalometric radiograph

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Skeletal midface and lower face heights in vertical plane on lateral cephalometric radiograph

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • Angulation and position of the upper central incisor on lateral cephalometric radiograph

    Before expansion(T1),through expansion completion an average 1 month(T2),and through retention completion an average 3 months(T3)

  • +1 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

Crossbite Side

Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

Positive Control Group

EXPERIMENTAL

Non-cossbite Side

Device: A locked modified acrylic bonded rapid maxillary expansion appliance (ARME)

Interventions

asymmetric maxillary expansion

Also known as: Narrow maxillary half intended for expansion or crossbite side
Treatment Group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • mixed dentition
  • true unilateral posterior crossbite
  • erupted first permanent molars and incisors
  • all deciduous canines and molars or no more than one missing deciduous molar
  • no history of orthodontic treatment
  • no systemic disease
  • no pathological periodontal status
  • no excessive gagging reflex.

You may not qualify if:

  • poor oral hygiene
  • caries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Toroglu MS, Uzel E, Kayalioglu M, Uzel I. Asymmetric maxillary expansion (AMEX) appliance for treatment of true unilateral posterior crossbite. Am J Orthod Dentofacial Orthop. 2002 Aug;122(2):164-73. doi: 10.1067/mod.2002.125563.

  • da Silva Filho OG, Boas MC, Capelozza Filho L. Rapid maxillary expansion in the primary and mixed dentitions: a cephalometric evaluation. Am J Orthod Dentofacial Orthop. 1991 Aug;100(2):171-9. doi: 10.1016/s0889-5406(05)81524-0.

  • Sari Z, Uysal T, Usumez S, Basciftci FA. Rapid maxillary expansion. Is it better in the mixed or in the permanent dentition? Angle Orthod. 2003 Dec;73(6):654-61. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Celal Irgın, Asst.Prof.

    Selcuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Split-mouth model. The crossbite side of the patients was assigned as the treatment group, while the normal bite or non-crossbite side of the same patients was assigned as the positive control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 18, 2024

First Posted

July 3, 2024

Study Start

April 1, 2007

Primary Completion

April 1, 2009

Study Completion

January 1, 2010

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The study will be made available for sharing as soon as it has been turned into an article.