Clinical trial NCT04828213: Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues
Official title: Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Crossbite
Keywords: stereophotogrammetry
Tooth-bone-borne rapid maxillary expansion
skeletal anchorage
mini-screws
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm parallel trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increasing soft tissue facial measurement-1
timeFrame: At baseline and after 3 months retention period
measure: Increasing soft tissue facial measurement-2
timeFrame: At baseline and after 3 months retention period
measure: Increasing soft tissue facial measurement-3
timeFrame: At baseline and after 3 months retention period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Akan B, Gokce G, Sahan AO, Veli I. Tooth-borne versus tooth-bone-borne rapid maxillary expanders according to a stereophotogrammetric evaluation of facial soft tissues: A randomized clinical trial. Orthod Craniofac Res. 2021 Aug;24(3):438-448. doi: 10.1111/ocr.12509. Epub 2021 Jun 21.