xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009796</url>
    </required_header>
    <id_info>
      <org_study_id>TDH-2022-12101</org_study_id>
      <nct_id>NCT06009796</nct_id>
    </id_info>
    <brief_title>The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance</brief_title>
    <official_title>The Effects of Various Rapid Palatal Expansion Appliances on Dentoskeletal, Dentoalveolar, Nasal and Airway Resistance: A Prospective, Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>TC Erciyes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>TC Erciyes University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance,&#xD;
        and airway changes by applying rapid palatal expansion appliances in patients with maxillary&#xD;
        constriction and the post-pubertal growth spurt stage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of&#xD;
        age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9&#xD;
        years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14,&#xD;
        15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth&#xD;
        group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory&#xD;
        evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior&#xD;
        radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory&#xD;
        polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior&#xD;
        to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests&#xD;
        were used to compare the expansion appliances.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 11, 2022</start_date>
    <completion_date type="Actual">July 12, 2023</completion_date>
    <primary_completion_date type="Actual">March 14, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rhinomanometry Measurement Parameters (Pa/cm3/sn )</measure>
      <time_frame>up to 1 year</time_frame>
      <description>-Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Polygraphy Measurement Parameters (event/hour)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>- Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postero-anterior Measurement Parameters(mm)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>NCB-NCB': Distance between right and left nasal cavity borders(mm)&#xD;
  JP-JP' : Distance between right and left jugal processes(mm)&#xD;
  AGP-AGP' : Distance between right and left antagonial points(mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Model Measurement Parameters(mm)</measure>
      <time_frame>up to 1 year</time_frame>
      <description>C-C : Distance between cusp crests of canines(mm)&#xD;
  C'-C' : Distance between cingulum of canines(mm)&#xD;
  M1-M1 : The distance between buccal tubercles of first molar(mm)&#xD;
  M1'-M1' : The distance between the lingual tubercles of first molar(mm)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">58</enrollment>
    <condition>Transverse Maxillary Deficiency</condition>
    <arm_group>
      <arm_group_label>Full Coverage Rapid Palatal Expansion (FCRPE) group:</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Modified McNamara Rapid Palatal Expansion (MMRPE) Group:</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tooth Tissue Borne Rapid Palatal Expansion</intervention_name>
      <description>In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.</description>
      <arm_group_label>Full Coverage Rapid Palatal Expansion (FCRPE) group:</arm_group_label>
      <arm_group_label>Modified McNamara Rapid Palatal Expansion (MMRPE) Group:</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Tooth Bone Borne Rapid Palatal Expansion</intervention_name>
      <description>After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.</description>
      <arm_group_label>Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  With a unilateral or bilateral morphological lateral crossbite&#xD;
  &#xD;
            -  Whose first molars and premolars had completely erupted at pretreatment&#xD;
  &#xD;
            -  With maxillary constriction of more than 4 mm and less than 10 mm&#xD;
  &#xD;
            -  Who were going through the post-pubertal growth spurt stage based on hand-wrist&#xD;
               radiographs&#xD;
  &#xD;
            -  Individuals with a body mass index of 18-24&#xD;
  &#xD;
            -  Individuals with an ANB angle between 0º and 4º&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  craniofacial anomalies&#xD;
  &#xD;
            -  compliance problems&#xD;
  &#xD;
            -  systemic or genetic disease&#xD;
  &#xD;
            -  previous orthodontic treatment history&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmet YAGCI, PROFESSOR</last_name>
      <role>Study Director</role>
      <affiliation>Erciyes University Faculty of Dentistry</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Erciyes University Faculty of Dentistry ,Department of Orthodontics</name>
        <address>
          <city>Kayseri</city>
          <zip>38000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141.</citation>
      <PMID>15782523</PMID>
    </reference>
    <reference>
      <citation>Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065.</citation>
      <PMID>20685540</PMID>
    </reference>
    <reference>
      <citation>Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17.</citation>
      <PMID>21683264</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>TC Erciyes University</investigator_affiliation>
      <investigator_full_name>Ahmet Yağcı</investigator_full_name>
      <investigator_title>PROFESSOR</investigator_title>
    </responsible_party>
    <keyword>Maxillary expansion</keyword>
    <keyword>Respiratory polygraphy</keyword>
    <keyword>Rhinomanometry</keyword>
    <keyword>MARPE</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009796
  org study id: TDH-2022-12101
  nct id: NCT06009796
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate the effects of dentoalveolar, dentoskeletal, nasal resistance,
        and airway changes by applying rapid palatal expansion appliances in patients with maxillary
        constriction and the post-pubertal growth spurt stage.
  Fifty eight patients were divided into 4 groups. The first group (n: 15, 15.6 ± 1,1 years of
        age) was Full Coverage Rapid Palatal Expansion (FCRPE). The second group ( n:14, 15.3 ± 0,9
        years of age) was Modified McNamara Rapid Palatal Expansion (MMRPE). The third group (n:14,
        15.7 ± 1,1 years of age) was Miniimplant Assisted Rapid Palatal Expansion (MARPE). The fourth
        group (n:15, 15.4 ± 1,0 years of age) was control group. Polygraphy for respiratory
        evaluation, rhinomanometry for nasal airway resistance, study model, and posteroanterior
        radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory
        polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior
        to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests
        were used to compare the expansion appliances.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Fifty eight patients were divided into 4 groups: FCRPE group (n: 15, 15.6 ± 1,1 years of age), MMRPE group (n:14, 15.3 ± 0,9 years of age), MARPE group (n:14, 15.7 ± 1,1 years of age), Control group (n:15, 15.4 ± 1,0 years of age). Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance, study model and posteroanterior radiographs (PA) to measure dentoalveolar and dentoskeletal effects were used. Respiratory polygraphy, rhinomanometry, study model, and posteroanterior radiographs were obtained prior to treatment and after 3 months of expansion. Paired t tests and independent-sample t tests were used to compare the expansion appliances.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rhinomanometry Measurement Parameters (Pa/cm3/sn )
  time frame: up to 1 year
  description: -Total Nasal Resistance(Pa/cm3/sn ): In our study, total nasal resistance was measured with a rhinomanometry device.
  measure: Polygraphy Measurement Parameters (event/hour)
  time frame: up to 1 year
  description: - Apnea-Hypopnea Index (event/hour) : In our study, Apnea-Hypopnea Index(AHI) was measured with a polygraphy device. - Oxygen Desaturation index (De SPO2) : In our study, De SPO2 was measured with a polygraphy device.
  measure: Postero-anterior Measurement Parameters(mm)
  time frame: up to 1 year
  description: NCB-NCB': Distance between right and left nasal cavity borders(mm)
  JP-JP' : Distance between right and left jugal processes(mm)
  AGP-AGP' : Distance between right and left antagonial points(mm)
  measure: Model Measurement Parameters(mm)
  time frame: up to 1 year
  description: C-C : Distance between cusp crests of canines(mm)
  C'-C' : Distance between cingulum of canines(mm)
  M1-M1 : The distance between buccal tubercles of first molar(mm)
  M1'-M1' : The distance between the lingual tubercles of first molar(mm)
  arm group label: Full Coverage Rapid Palatal Expansion (FCRPE) group:
  arm group type: Active Comparator
  description: Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of all maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.
  arm group label: Modified McNamara Rapid Palatal Expansion (MMRPE) Group:
  arm group type: Active Comparator
  description: Impressions were taken from the maxilla using alginate to obtain study models. In the obtained study model, a 10 mm hyrax expansion screw (Dentarum®, Germany) was placed at the midline as close to the palate as possible and parallel to the occlusal plane. The vestibular, occlusal, and palatal surfaces of the posterior maxillary teeth are covered in acrylic, and this acrylic support extends toward the median palatal suture in the palatal region. Under pressure, the acrylic appliance was polymerized.
  arm group label: Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group
  arm group type: Active Comparator
  description: The MARPE appliance was composed of a central expansion jackscrew (Dentarum), 4 tubes, 2 bands on the upper first molars to facilitate placement of the appliance, and 1.5-mm diameter stainless steel arms extending to the premolar teeth. Soldered stainless steel tubes (internal diameter: 2.0 mm; external diameter: 3.0 mm; length: 2.0 mm) served as guides for miniscrew placement. The size of the screws (PSM) was chosen as 1.8 mm in diameter and 11 mm in length, considering the 2 mm height of the tubes, 1 to 2 mm gap between the appliance and the palate surface, 1 to 2 mm gingiva thickness, and 5 to 6 mm length required for the bicortical placement of the screw in the bone.
  arm group label: Control Group
  arm group type: No Intervention
  description: A control group in the same age, without maxillary constriction was also added to our study.Polygraphy for respiratory evaluation, rhinomanometry for nasal airway resistance were used. Polygraphy and rhinomanometry measurements were obtained at the beginning of the follow-up and at the end of the 4-month follow-up period.
  intervention type: Device
  intervention name: Tooth Tissue Borne Rapid Palatal Expansion
  description: In all rapid palatal expansion groups, the appliances were cis bonded after being made by the same technician. The expansion screw was turned twice a day until the desired width was achieved.
  arm group label: Full Coverage Rapid Palatal Expansion (FCRPE) group:
  arm group label: Modified McNamara Rapid Palatal Expansion (MMRPE) Group:
  intervention type: Device
  intervention name: Tooth Bone Borne Rapid Palatal Expansion
  description: After the Marpe appliance was attached, 4 miniscrews were applied to the midline of the palate with a miniscrew driver. The expansion screw was turned twice a day until the desired width was achieved.
  arm group label: Miniimplant Assisted Rapid Palatal Expansion (MARPE) Group
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmet YAGCI, PROFESSOR
  role: Study Director
  affiliation: Erciyes University Faculty of Dentistry
  facility: 
  country: Turkey
  citation: Lagravere MO, Major PW, Flores-Mir C. Skeletal and dental changes with fixed slow maxillary expansion treatment: a systematic review. J Am Dent Assoc. 2005 Feb;136(2):194-9. doi: 10.14219/jada.archive.2005.0141.
  PMID: 15782523
  citation: Lee KJ, Park YC, Park JY, Hwang WS. Miniscrew-assisted nonsurgical palatal expansion before orthognathic surgery for a patient with severe mandibular prognathism. Am J Orthod Dentofacial Orthop. 2010 Jun;137(6):830-9. doi: 10.1016/j.ajodo.2007.10.065.
  PMID: 20685540
  citation: Seeberger R, Kater W, Schulte-Geers M, Davids R, Freier K, Thiele O. Changes after surgically-assisted maxillary expansion (SARME) to the dentoalveolar, palatal and nasal structures by using tooth-borne distraction devices. Br J Oral Maxillofac Surg. 2011 Jul;49(5):381-5. doi: 10.1016/j.bjoms.2010.05.015. Epub 2010 Jun 17.
  PMID: 21683264
  responsible party type: Principal Investigator
  investigator affiliation: TC Erciyes University
  investigator full name: Ahmet Yağcı
  investigator title: PROFESSOR
  sharing ipd: No