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

NCT04828213 | Completed

• 1 other identifier: 2017-GAP-DİŞF-0003
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posterior Crossbite

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Increasing soft tissue facial measurement-1

  Increasing anterior face height

  At baseline and after 3 months retention period

• Increasing soft tissue facial measurement-2

  Increasing upper lip length

  At baseline and after 3 months retention period

• Increasing soft tissue facial measurement-3

  Increasing lower face height

  At baseline and after 3 months retention period

Study Arms (2)

Tooth-borne RME appliance (Hyrax)

EXPERIMENTAL

In the Tooth-borne RME expander group, bands were placed to the maxillary right and left upper 1st premolar and 1st molar teeth. The impression of the upper jaw was obtained with the bands in mouth by using alginate impression material. In the laboratory process, a hyrax (Forestadent, Pforzheim, Germany; Forestadent USA, St Louis, Missouri, USA) expansion appliance with an expansion screw in the middle was prepared on the models by the same technician under standard conditions. 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.

Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax); Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance

Hybrid hyrax RME appliance

EXPERIMENTAL

Rapid Maxillary Expansion Treatment. In the Hybrid hyrax RME appliance group, mini-screws of 2 mm diameter and 9 mm length (Benefit mini-implants; PSM Medical Solutions; Tuttlingen, Germany) were placed 3 mm posterior and 1 to 5 mm paramedian to the incisive foramina. 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.

Device: Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax); Device: Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance

Interventions

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

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.

Hybrid hyrax RME appliance; Tooth-borne RME appliance (Hyrax)

Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance DEVICE

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.

Hybrid hyrax RME appliance; Tooth-borne RME appliance (Hyrax)

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gökçenur Gökçe: lead

Related Publications (1)

• 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.

  PMID: 34105880 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Model Details: 2-arm parallel trial

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 1, 2021
• Study Start: May 20, 2016
• Primary Completion: February 14, 2017
• Study Completion: July 17, 2017
• Last Updated: April 1, 2021

Record last verified: 2021-03