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Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues

Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04828213
Enrollment
32
Registered
2021-04-01
Start date
2016-05-20
Completion date
2017-07-17
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Crossbite

Keywords

stereophotogrammetry, Tooth-bone-borne rapid maxillary expansion, skeletal anchorage, mini-screws

Brief summary

The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.

Detailed description

Introduction: To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P\<0.05 significance level.

Interventions

DEVICERapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax)

The patients were treated with a expansion appliance containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.

DEVICERapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance

The patients were treated with a Hybrid hyrax RME appliance containing a Hyrax expansion screw positioned parallel to the second premolars and mini-screws. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.

Sponsors

Gökçenur Gökçe
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double (Participant, Outcomes Assessor)

Intervention model description

2-arm parallel trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

1. No previous tonsillar, nasal or adenoid surgery and orthodontic treatment, 2. Bilateral crossbite and need for RME, 3. Maxillary and mandibular permanent teeth fully erupted, 4. Willingness to participate in the study

Exclusion criteria

1. the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy 2. Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene, 3. History of previous orthodontic treatment.

Design outcomes

Primary

MeasureTime frameDescription
Increasing soft tissue facial measurement-1At baseline and after 3 months retention periodIncreasing anterior face height
Increasing soft tissue facial measurement-2At baseline and after 3 months retention periodIncreasing upper lip length
Increasing soft tissue facial measurement-3At baseline and after 3 months retention periodIncreasing lower face height

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026