<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/NCT04427397</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000432</org_study_id>
    <nct_id>NCT04427397</nct_id>
  </id_info>
  <brief_title>Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush</brief_title>
  <official_title>The Effects of Using the Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush in Reducing Bleeding on Probing and Plaque Removal: A Randomized Control Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tufts 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>
      In this study, all subjects will be given an electric toothbrush. Half of the participants&#xD;
      will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of&#xD;
      participants will be asked to follow the brushing instructions in the user manual. The&#xD;
      study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing&#xD;
      bleeding on probing with the use of an electric toothbrush used without personal professional&#xD;
      instruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bleeding on probing (BOP)</measure>
    <time_frame>Baseline through study completion, an average of 4 months</time_frame>
    <description>To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness of professional cleaning</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>To compare whether a dental professional's (DP) cleaning a subject's teeth using an electric toothbrush with the SBTT is more effective in removing cervical plaque than the patient self-cleaning using electric toothbrush with the SBTT at the initial visit and after four months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in plaque</measure>
    <time_frame>Baseline and 4 months</time_frame>
    <description>To compare the plaque removal of each subject at the initial visit with their plaque removal after four months of using the SBTT. To compare the plaque removal of the DP at the initial visit with the DP's plaque removal at the fourth month visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluating deformation of toothbrush bristles</measure>
    <time_frame>Baseline through study completion, an average of 4 months</time_frame>
    <description>To compare the deformation of toothbrush bristles when used by patients using the SBTT with an electric toothbrush with the deformation of the toothbrush bristles with patients using an electric toothbrush uninstructed and whether the deformation is associated with BoP in each group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Gum Bleed</condition>
  <arm_group>
    <arm_group_label>Sulcular Bristle Tip Technique (SBTT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>User manual of the electric toothbrush (DFU)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This control group will be asked to read and use the instructions found in the user manual of the electric toothbrush (DFU). No formal instruction will be provided. The DFU accompany the electric toothbrush regardless of the subject's participation in the research.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sulcular Bristle Tip Technique (SBTT)</intervention_name>
    <description>Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice.</description>
    <arm_group_label>Sulcular Bristle Tip Technique (SBTT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Subjects must show &gt; 20% buccal/lingual cervical sites with bleeding on probing (BoP)&#xD;
&#xD;
          -  Subjects must have &gt; 24 natural teeth excluding third molars&#xD;
&#xD;
          -  Subjects must have had a professional dental prophylaxis within three months of&#xD;
             beginning the study&#xD;
&#xD;
          -  Subjects must be willing to brush with electric toothbrush twice daily.&#xD;
&#xD;
          -  Subjects who are randomized into Group 1 must be willing to be taught and to&#xD;
             demonstrate the SBTT&#xD;
&#xD;
          -  Subjects who are randomized into Group 2 must be willing to follow the Sonicare DFU&#xD;
             from Philips Oral Healthcare; however, will otherwise be uninstructed until after the&#xD;
             study has been completed&#xD;
&#xD;
          -  Subjects must be willing to refrain from any oral hygiene for at least 12-18 hours&#xD;
             prior to each study follow-up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who use tobacco products&#xD;
&#xD;
          -  Subjects who are currently pregnant (self-reported) due to the greater bleeding&#xD;
             tendency caused by hormonal changes&#xD;
&#xD;
          -  Subjects with fixed or removable orthodontic appliances&#xD;
&#xD;
          -  Subjects whose restorations violate or potentially violate the biologic width.&#xD;
&#xD;
          -  Subjects with irregular restoration margins or overhanging margins within 1mm of the&#xD;
             crest of the marginal gingiva.&#xD;
&#xD;
          -  Antibiotic treatment at the time of the initial examination or during the month prior&#xD;
&#xD;
          -  Subjects with cervical probing depth &gt;3 mm&#xD;
&#xD;
          -  Subjects with systemic diseases that affect the gingiva&#xD;
&#xD;
          -  Subjects taking medications that affect the gingiva&#xD;
&#xD;
          -  Subjects who cannot read/write/speak English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Livia Valverde, DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts University School of Dental Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Livia Valverde, DMD</last_name>
    <phone>617-636-6828</phone>
    <email>Livia.Valverde@tufts.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tufts University School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Livia Valverde, DMD</last_name>
      <email>Livia.Valverde@tufts.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 9, 2022</last_update_submitted>
  <last_update_submitted_qc>March 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tufts University School of Dental Medicine</investigator_affiliation>
    <investigator_full_name>Livia Valverde</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sulcular bristle tip technique</keyword>
  <keyword>SBTT</keyword>
  <keyword>brushing</keyword>
  <keyword>plaque</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT04427397
org study id: STUDY00000432
nct id: NCT04427397
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, all subjects will be given an electric toothbrush. Half of the participants
      will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of
      participants will be asked to follow the brushing instructions in the user manual. The
      study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing
      bleeding on probing with the use of an electric toothbrush used without personal professional
      instruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Change in bleeding on probing (BOP)
time frame: Baseline through study completion, an average of 4 months
description: To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.
measure: Effectiveness of professional cleaning
time frame: Baseline and 4 months
description: To compare whether a dental professional's (DP) cleaning a subject's teeth using an electric toothbrush with the SBTT is more effective in removing cervical plaque than the patient self-cleaning using electric toothbrush with the SBTT at the initial visit and after four months
measure: Change in plaque
time frame: Baseline and 4 months
description: To compare the plaque removal of each subject at the initial visit with their plaque removal after four months of using the SBTT. To compare the plaque removal of the DP at the initial visit with the DP's plaque removal at the fourth month visit.
measure: Evaluating deformation of toothbrush bristles
time frame: Baseline through study completion, an average of 4 months
description: To compare the deformation of toothbrush bristles when used by patients using the SBTT with an electric toothbrush with the deformation of the toothbrush bristles with patients using an electric toothbrush uninstructed and whether the deformation is associated with BoP in each group.
arm group label: Sulcular Bristle Tip Technique (SBTT)
arm group type: Experimental
description: This test group will receive formal instruction on the Sulcular Bristle Tip Technique (SBTT).
arm group label: User manual of the electric toothbrush (DFU)
arm group type: No Intervention
description: This control group will be asked to read and use the instructions found in the user manual of the electric toothbrush (DFU). No formal instruction will be provided. The DFU accompany the electric toothbrush regardless of the subject's participation in the research.
intervention type: Other
intervention name: Sulcular Bristle Tip Technique (SBTT)
description: Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice.
arm group label: Sulcular Bristle Tip Technique (SBTT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Livia Valverde, DMD
role: Principal Investigator
affiliation: Tufts University School of Dental Medicine
last name: Livia Valverde, DMD
phone: 617-636-6828
email: Livia.Valverde@tufts.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Tufts University School of Dental Medicine
investigator full name: Livia Valverde
investigator title: Assistant Professor
mesh term: Gingival Hemorrhage