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

Posterior Crossbite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828213
• Other study ID #: 2017-GAP-DISF-0003
• Status: Completed
• Phase: N/A
• Start date: May 20, 2016
• Est. completion date: July 17, 2017

Study information

• Verified date: March 2021
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 17, 2017
• Est. primary completion date: February 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malocclusion
• Posterior Crossbite

Intervention

Device:
• Rapid 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.
• Rapid 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gökçenur Gökçe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increasing soft tissue facial measurement-1	Increasing anterior face height	At baseline and after 3 months retention period
Primary	Increasing soft tissue facial measurement-2	Increasing upper lip length	At baseline and after 3 months retention period
Primary	Increasing soft tissue facial measurement-3	Increasing lower face height	At baseline and after 3 months retention period