<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/NCT03753256</url>
  </required_header>
  <id_info>
    <org_study_id>S-370/2015</org_study_id>
    <nct_id>NCT03753256</nct_id>
  </id_info>
  <brief_title>Evaluation of Optical Coherence Tomography in Dentistry</brief_title>
  <official_title>Evaluation of Optical Coherence Tomography in Dentistry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Heidelberg Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heidelberg Engineering GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Heidelberg Medical Center</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>
      Optical coherence tomography (OCT) is a medical diagnostic tool, providing non-invasive,&#xD;
      non-radiative and high resolution imaging. OCT has been established since many years in&#xD;
      ophthalmology. In dentistry the diagnostic potential of OCT is currently increasingly being&#xD;
      noticed. This clinical study includes two individual trials: (i) Longitudinal assessment of&#xD;
      surface sealant thickness using optical coherence tomography and (ii) comparison of&#xD;
      crevicular fluid levels of inflammatory cytokines after the application of surface sealants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial 1: Evaluation of the abrasion behavior of the orthodontic surface sealants Pro Seal®,&#xD;
      Opal®Seal, and Protecto®CaF2Nano. The quadrants of 20 participants will be randomly assigned&#xD;
      to four study groups. Using a split mouth design three commonly used orthodontic surface&#xD;
      sealants (Pro Seal®, Opal®Seal, and Protecto®CaF2Nano) and a bonding primer (Transbond XT)&#xD;
      which is used as a control will be applied to the labial surfaces of the teeth of the&#xD;
      respective quadrants. The thickness changes of the orthodontic surface sealants and the&#xD;
      development of enamel demineralization will be monitored at the day of the application and&#xD;
      five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12&#xD;
      months) using OCT.&#xD;
&#xD;
      Trial 2: Evaluation of Adverse effects of orthodontic surface sealants. 15 quadrants of the&#xD;
      trial group described above (Trial1) will be randomly selected and gingival crevicular fluid&#xD;
      (GCF) will be sampled in the respective quadrants at the day of bracket bonding prior (t0)&#xD;
      and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the&#xD;
      application of surface sealants or the bonding primer, respectively. Analysis will be&#xD;
      performed using magnetic Luminex screening assays for IL-8 (Interleukin 8), and IL-10&#xD;
      (Interleukin 10) and examined for inflammatory cytokines after the application of surface&#xD;
      sealants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abrasion behaviour of orthodontic surface sealants</measure>
    <time_frame>The thickness changes of the orthodontic surface sealants and the development of enamel demineralization will be monitored at the day of the application and five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12 months)</time_frame>
    <description>Longitudinal assesment of surface sealant thickness using optical coherence tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse effects of orthodontic surface sealants</measure>
    <time_frame>To assess cytokine levels GCF will be sampled at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer, respectively.</time_frame>
    <description>To evaluate possible adverse effects of orthodontic surface sealants in vivo gingival crevicular fluid will be sampled in the respective quadrants at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer. Existing data on possible adverse effects of resin monomers from restorative composites or surface sealants were obtained using 3D tissue models; therefore, in the present study the investigators will attempt to evaluate possible adverse effects of commonly used smooth surface sealants on gingival tissues by analysing inflammatory cytokines in crevicular fluid of the participants after the application of surface sealants.To this end, the levels of the inflammatory cytokines (IL-8 (Interleukin 8), and IL-10 (Interleukin 10) in GCF will be assessed using multiplex analysis.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dental Caries</condition>
  <condition>Tooth Demineralization</condition>
  <arm_group>
    <arm_group_label>Transbond XT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of different orthodontic surface sealants to participants:&#xD;
Randomly assigned quadrants in this arm will receive a bonding primer (Transbond XT) The investigators will evaluate in this arm&#xD;
the development of demineralization&#xD;
its adverse effects after application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Protecto®CaF2Nano</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of different orthodontic surface sealants to participants:&#xD;
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Protecto®CaF2Nano).&#xD;
The investigators will evaluate in this arm&#xD;
its abrasion behavior and the development of demineralization&#xD;
its adverse effects after the application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pro Seal®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of different orthodontic surface sealants to participants:&#xD;
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Pro Seal®).&#xD;
The investigators will evaluate in this arm&#xD;
its abrasion behavior and the development of demineralization&#xD;
its adverse effects after the application</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opal® Seal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of different orthodontic surface sealants to participants:&#xD;
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Opal®Seal).&#xD;
The investigators will evaluate in this arm&#xD;
its abrasion behavior and the development of demineralization&#xD;
its adverse effects after the application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transbond XT</intervention_name>
    <description>Application of&#xD;
• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.</description>
    <arm_group_label>Transbond XT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Protecto®CaF2Nano</intervention_name>
    <description>Application of&#xD;
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.</description>
    <arm_group_label>Protecto®CaF2Nano</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pro Seal®</intervention_name>
    <description>Application of&#xD;
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.</description>
    <arm_group_label>Pro Seal®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Opal®Seal</intervention_name>
    <description>Application of&#xD;
• Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.</description>
    <arm_group_label>Opal® Seal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Orthodontic treatment need&#xD;
&#xD;
          -  Informed consent from all patients and their parents or legal guardians after&#xD;
             explaining of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • withdrawn consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sinan Sen, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sinan Sen, Dr.</last_name>
    <phone>0049622156</phone>
    <phone_ext>6583</phone_ext>
    <email>sinan.sen@med.uni-heidelberg.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sinan Sen, Dr.</last_name>
      <phone>0049622156</phone>
      <phone_ext>6583</phone_ext>
      <email>sinan.sen@med.uni-heidelberg.de</email>
    </contact>
    <contact_backup>
      <last_name>Sebastian Zingler, Dr.</last_name>
      <phone>004956</phone>
      <phone_ext>36565</phone_ext>
      <email>sebastian.zingler@med.uni-heidelberg.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Alsayed EZ, Hariri I, Sadr A, Nakashima S, Bakhsh TA, Shimada Y, Sumi Y, Tagami J. Optical coherence tomography for evaluation of enamel and protective coatings. Dent Mater J. 2015;34(1):98-107. doi: 10.4012/dmj.2014-215.</citation>
    <PMID>25748465</PMID>
  </results_reference>
  <results_reference>
    <citation>Levin SM. Portasystemic shunts for portal hypertension: early and late results in a personal series of 140 operations. Vasc Surg. 1974 Jan-Feb;8(1):20-5. No abstract available.</citation>
    <PMID>4544493</PMID>
  </results_reference>
  <results_reference>
    <citation>Ryf S, Flury S, Palaniappan S, Lussi A, van Meerbeek B, Zimmerli B. Enamel loss and adhesive remnants following bracket removal and various clean-up procedures in vitro. Eur J Orthod. 2012 Feb;34(1):25-32. doi: 10.1093/ejo/cjq128. Epub 2011 Jan 12.</citation>
    <PMID>21228118</PMID>
  </results_reference>
  <results_reference>
    <citation>Lee SH, Lee JJ, Chung HJ, Park JT, Kim HJ. Dental optical coherence tomography: new potential diagnostic system for cracked-tooth syndrome. Surg Radiol Anat. 2016 Jan;38(1):49-54. doi: 10.1007/s00276-015-1514-8. Epub 2015 Jul 14.</citation>
    <PMID>26168856</PMID>
  </results_reference>
  <results_reference>
    <citation>Leao Filho JC, Braz AK, de Araujo RE, Tanaka OM, Pithon MM. Enamel Quality after Debonding: Evaluation by Optical Coherence Tomography. Braz Dent J. 2015 Jul-Aug;26(4):384-9. doi: 10.1590/0103-6440201300406.</citation>
    <PMID>26312977</PMID>
  </results_reference>
  <results_reference>
    <citation>Zingler S, Sommer A, Sen S, Saure D, Langer J, Guillon O, Lux CJ. Efficiency of powered systems for interproximal enamel reduction (IER) and enamel roughness before and after polishing-an in vitro study. Clin Oral Investig. 2016 Jun;20(5):933-42. doi: 10.1007/s00784-015-1585-2. Epub 2015 Sep 30. Erratum In: Clin Oral Investig. 2016 Nov;20(8):2323.</citation>
    <PMID>26419674</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>April 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Heidelberg Medical Center</investigator_affiliation>
    <investigator_full_name>Sinan Sen</investigator_full_name>
    <investigator_title>Senior Teaching and Research Assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
    <mesh_term>Tooth Demineralization</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03753256
org study id: S-370/2015
nct id: NCT03753256
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Optical coherence tomography (OCT) is a medical diagnostic tool, providing non-invasive,
      non-radiative and high resolution imaging. OCT has been established since many years in
      ophthalmology. In dentistry the diagnostic potential of OCT is currently increasingly being
      noticed. This clinical study includes two individual trials: (i) Longitudinal assessment of
      surface sealant thickness using optical coherence tomography and (ii) comparison of
      crevicular fluid levels of inflammatory cytokines after the application of surface sealants.
Trial 1: Evaluation of the abrasion behavior of the orthodontic surface sealants Pro Seal®,
      Opal®Seal, and Protecto®CaF2Nano. The quadrants of 20 participants will be randomly assigned
      to four study groups. Using a split mouth design three commonly used orthodontic surface
      sealants (Pro Seal®, Opal®Seal, and Protecto®CaF2Nano) and a bonding primer (Transbond XT)
      which is used as a control will be applied to the labial surfaces of the teeth of the
      respective quadrants. The thickness changes of the orthodontic surface sealants and the
      development of enamel demineralization will be monitored at the day of the application and
      five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12
      months) using OCT.

      Trial 2: Evaluation of Adverse effects of orthodontic surface sealants. 15 quadrants of the
      trial group described above (Trial1) will be randomly selected and gingival crevicular fluid
      (GCF) will be sampled in the respective quadrants at the day of bracket bonding prior (t0)
      and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the
      application of surface sealants or the bonding primer, respectively. Analysis will be
      performed using magnetic Luminex screening assays for IL-8 (Interleukin 8), and IL-10
      (Interleukin 10) and examined for inflammatory cytokines after the application of surface
      sealants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Investigator)
measure: Abrasion behaviour of orthodontic surface sealants
time frame: The thickness changes of the orthodontic surface sealants and the development of enamel demineralization will be monitored at the day of the application and five additional time points (t1= 1 month, t2= 3 months, t3= 6 months, t4=9 months, t5= 12 months)
description: Longitudinal assesment of surface sealant thickness using optical coherence tomography
measure: Adverse effects of orthodontic surface sealants
time frame: To assess cytokine levels GCF will be sampled at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer, respectively.
description: To evaluate possible adverse effects of orthodontic surface sealants in vivo gingival crevicular fluid will be sampled in the respective quadrants at the day of bracket bonding prior (t0) and at three additional time points (t1= 30 min, t2= 60 min, t3= 90 min) after the application of surface sealants or the bonding primer. Existing data on possible adverse effects of resin monomers from restorative composites or surface sealants were obtained using 3D tissue models; therefore, in the present study the investigators will attempt to evaluate possible adverse effects of commonly used smooth surface sealants on gingival tissues by analysing inflammatory cytokines in crevicular fluid of the participants after the application of surface sealants.To this end, the levels of the inflammatory cytokines (IL-8 (Interleukin 8), and IL-10 (Interleukin 10) in GCF will be assessed using multiplex analysis.
arm group label: Transbond XT
arm group type: Active Comparator
description: Application of different orthodontic surface sealants to participants:
Randomly assigned quadrants in this arm will receive a bonding primer (Transbond XT) The investigators will evaluate in this arm
the development of demineralization
its adverse effects after application
arm group label: Protecto®CaF2Nano
arm group type: Experimental
description: Application of different orthodontic surface sealants to participants:
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Protecto®CaF2Nano).
The investigators will evaluate in this arm
its abrasion behavior and the development of demineralization
its adverse effects after the application
arm group label: Pro Seal®
arm group type: Experimental
description: Application of different orthodontic surface sealants to participants:
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Pro Seal®).
The investigators will evaluate in this arm
its abrasion behavior and the development of demineralization
its adverse effects after the application
arm group label: Opal® Seal
arm group type: Experimental
description: Application of different orthodontic surface sealants to participants:
Randomly assigned quadrants in this arm will receive an orthodontic surface sealant (Opal®Seal).
The investigators will evaluate in this arm
its abrasion behavior and the development of demineralization
its adverse effects after the application
intervention type: Device
intervention name: Transbond XT
description: Application of
• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants.
arm group label: Transbond XT
intervention type: Device
intervention name: Protecto®CaF2Nano
description: Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
arm group label: Protecto®CaF2Nano
intervention type: Device
intervention name: Pro Seal®
description: Application of
• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
arm group label: Pro Seal®
intervention type: Device
intervention name: Opal®Seal
description: Application of
• Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants.
arm group label: Opal® Seal
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Sinan Sen, Dr.
role: Study Director
affiliation: Department of Orthodontics and Dentofacial Orthopaedics, University of Heidelberg
last name: Sinan Sen, Dr.
phone: 0049622156
phone ext: 6583
email: sinan.sen@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: Alsayed EZ, Hariri I, Sadr A, Nakashima S, Bakhsh TA, Shimada Y, Sumi Y, Tagami J. Optical coherence tomography for evaluation of enamel and protective coatings. Dent Mater J. 2015;34(1):98-107. doi: 10.4012/dmj.2014-215.
PMID: 25748465
citation: Levin SM. Portasystemic shunts for portal hypertension: early and late results in a personal series of 140 operations. Vasc Surg. 1974 Jan-Feb;8(1):20-5. No abstract available.
PMID: 4544493
citation: Ryf S, Flury S, Palaniappan S, Lussi A, van Meerbeek B, Zimmerli B. Enamel loss and adhesive remnants following bracket removal and various clean-up procedures in vitro. Eur J Orthod. 2012 Feb;34(1):25-32. doi: 10.1093/ejo/cjq128. Epub 2011 Jan 12.
PMID: 21228118
citation: Lee SH, Lee JJ, Chung HJ, Park JT, Kim HJ. Dental optical coherence tomography: new potential diagnostic system for cracked-tooth syndrome. Surg Radiol Anat. 2016 Jan;38(1):49-54. doi: 10.1007/s00276-015-1514-8. Epub 2015 Jul 14.
PMID: 26168856
citation: Leao Filho JC, Braz AK, de Araujo RE, Tanaka OM, Pithon MM. Enamel Quality after Debonding: Evaluation by Optical Coherence Tomography. Braz Dent J. 2015 Jul-Aug;26(4):384-9. doi: 10.1590/0103-6440201300406.
PMID: 26312977
citation: Zingler S, Sommer A, Sen S, Saure D, Langer J, Guillon O, Lux CJ. Efficiency of powered systems for interproximal enamel reduction (IER) and enamel roughness before and after polishing-an in vitro study. Clin Oral Investig. 2016 Jun;20(5):933-42. doi: 10.1007/s00784-015-1585-2. Epub 2015 Sep 30. Erratum In: Clin Oral Investig. 2016 Nov;20(8):2323.
PMID: 26419674
responsible party type: Principal Investigator
investigator affiliation: University of Heidelberg Medical Center
investigator full name: Sinan Sen
investigator title: Senior Teaching and Research Assistant
mesh term: Dental Caries
mesh term: Tooth Demineralization
sharing ipd: No