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

Not Applicable

Completed

• Conditions: Posterior Crossbite

• Registration Number: NCT04828213
• Lead Sponsor: Gökçenur Gökçe

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.

Study Timeline

• Study Start: 2016-05-20
• Primary Completion: 2017-02-14
• Study Completion: 2017-07-17
• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-31
• Last Update Submitted: 2021-03-31
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Increasing soft tissue facial measurement-1	At baseline and after 3 months retention period	Increasing anterior face height
Increasing soft tissue facial measurement-2	At baseline and after 3 months retention period	Increasing upper lip length
Increasing soft tissue facial measurement-3	At baseline and after 3 months retention period	Increasing lower face height