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

Primary Purpose

Posterior Crossbite

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax)
Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance
Sponsored by
Gökçenur Gökçe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Crossbite focused on measuring stereophotogrammetry, Tooth-bone-borne rapid maxillary expansion, skeletal anchorage, mini-screws

Eligibility Criteria

12 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Tooth-borne RME appliance (Hyrax)

    Hybrid hyrax RME appliance

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Increasing soft tissue facial measurement-1
    Increasing anterior face height
    Increasing soft tissue facial measurement-2
    Increasing upper lip length
    Increasing soft tissue facial measurement-3
    Increasing lower face height

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2021
    Last Updated
    March 31, 2021
    Sponsor
    Gökçenur Gökçe
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04828213
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    May 20, 2016 (Actual)
    Primary Completion Date
    February 14, 2017 (Actual)
    Study Completion Date
    July 17, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Gökçenur Gökçe

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Crossbite
    Keywords
    stereophotogrammetry, Tooth-bone-borne rapid maxillary expansion, skeletal anchorage, mini-screws

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    2-arm parallel trial
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tooth-borne RME appliance (Hyrax)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Hybrid hyrax RME appliance
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax)
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Increasing soft tissue facial measurement-1
    Description
    Increasing anterior face height
    Time Frame
    At baseline and after 3 months retention period
    Title
    Increasing soft tissue facial measurement-2
    Description
    Increasing upper lip length
    Time Frame
    At baseline and after 3 months retention period
    Title
    Increasing soft tissue facial measurement-3
    Description
    Increasing lower face height
    Time Frame
    At baseline and after 3 months retention period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    34105880
    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.
    Results Reference
    derived

    Learn more about this trial

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

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