<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/NCT03750851</url>
  </required_header>
  <id_info>
    <org_study_id>UFPara-005</org_study_id>
    <nct_id>NCT03750851</nct_id>
  </id_info>
  <brief_title>CPP-ACPF and Laser's Effect on Dentin Hypersensitivity</brief_title>
  <official_title>CPP-ACPF and Low Level Laser Therapy Effect on Symptomatology and Quality of Life of People With Dentin Hypersensitivity: A Clinical, Randomized, Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Para</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Para</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study was to evaluate the effect of casein phosphopeptide amorphous calcium&#xD;
      phosphate fluoride paste (CPP-ACPF) associated with low level laser therapy (LLLT) in the&#xD;
      symptomatology and on the quality of life of the individuals with dentin hypersensitivity in&#xD;
      a randomized placebo-controlled clinical trial. Volunteers 18 to 50 years old with&#xD;
      hypersensitive teeth were randomized into 4 groups: GPlacebo - positioning of the laser tip&#xD;
      without light emission + placebo dentifrice; GCPPACPF - positioning of the laser tip without&#xD;
      light emission + CPP-ACPF application; GLaser - laser tip positioning with light emission +&#xD;
      placebo dentifrice; GLaserCPPACPF - positioning and light emission of the laser beam +&#xD;
      CPP-ACPF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      GLaser received the laser application using the infrared light spectrum with wavelength of&#xD;
      808 nm with its active AsGaAl medium in two points of the vestibular face of the&#xD;
      hypersensitive teeth. At each point it was applied 60 J / cm², for 16 seconds. Three laser's&#xD;
      sessions were applied with a time interval of 24 hours between them. GLaserCPPACPF first&#xD;
      received the CPPACPF application and then the laser application according to the&#xD;
      manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated&#xD;
      with a tester (MMOptics Ltda®, Brazil).&#xD;
&#xD;
      The GCPPACPF volunteers were submitted to the application of the CPPACPF'S containing tooth&#xD;
      paste MI Paste Plus™ (Recaldent™, GC América, USA) on the vestibular surfaces of&#xD;
      hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil)&#xD;
      for 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece&#xD;
      (500, Kavo, Germany) was used to scrub the desensitizing gel during 20 seconds on each tooth,&#xD;
      according to the manufacturer's specifications. GPlacebo followed the same protocol used in&#xD;
      GCPPACPF. In addition to the desensitizing treatments, all GCPPACPF and GPlacebo volunteers&#xD;
      received the positioning of the laser tip to mimic the light emission produced in GLaser and&#xD;
      GLaserCPPACPF. The noise emitted by the laser device was mimic through the sound reproduction&#xD;
      of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Actual">December 14, 2018</completion_date>
  <primary_completion_date type="Actual">December 7, 2018</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of treatment in dental sensitivity intensity change as assessed by VAS</measure>
    <time_frame>1 month</time_frame>
    <description>Self reported dentin sensitivity intensity before and after desensitizing treatment. Giving an score for each tooth by marking in the Visual Analogue Scale (VAS) from 0-10 (0-no pain and 10-pain as bad as it can be). With lower values representing a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life change</measure>
    <time_frame>1 month</time_frame>
    <description>Self reported dentin sensitivity intensity impact in the quality's of life before and after desensitizing treatment. By answering an specific questionnaire: Dentine Hypersensitivity Experience Questionnaire, measured in a likert scale from 7 to 1 (Where 7 is strongly agree and 1 is strongly disagree). With lower values representing a better outcome.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>GPlacebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson &amp; Johnson, Brazil) was applied to hypersensitive dentin. The GPlacebo volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GCPPACPF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLaser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 3 sessions with a time interval of 24 hours between them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GLaserCPPACPF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson &amp; Johnson, Brazil) was applied to hypersensitive dentin. The GPlacebo volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.</description>
    <arm_group_label>GPlacebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CPPACPF</intervention_name>
    <description>In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.</description>
    <arm_group_label>GCPPACPF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laser</intervention_name>
    <description>In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 3 sessions with a time interval of 24 hours between them.</description>
    <arm_group_label>GLaser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LaserCPPACPF</intervention_name>
    <description>In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.</description>
    <arm_group_label>GLaserCPPACPF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The presence of at least two hypersensitive teeth;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Milk's proteins allergy;&#xD;
&#xD;
          -  Systemic diseases;&#xD;
&#xD;
          -  Teeth with carious lesions or pulpitis;&#xD;
&#xD;
          -  Teeth with defective restorations;&#xD;
&#xD;
          -  Teeth with with cleft enamel;&#xD;
&#xD;
          -  Patients with active periodontal disease;&#xD;
&#xD;
          -  Patients with analgesic medication;&#xD;
&#xD;
          -  Patients with pregnant or lactating women&#xD;
&#xD;
          -  Patients who have received professional desensitizing treatment in the last three&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecy M Silva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>clinical professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Para's Federal University</name>
      <address>
        <city>Belém</city>
        <state>Pará</state>
        <zip>66075-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Para</investigator_affiliation>
    <investigator_full_name>Cecy Martins Silva</investigator_full_name>
    <investigator_title>PhD Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>desensitizing treatment</keyword>
  <keyword>dental hypersensitivity</keyword>
  <keyword>CPPACPF</keyword>
  <keyword>Low level laser therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03750851
org study id: UFPara-005
nct id: NCT03750851
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to evaluate the effect of casein phosphopeptide amorphous calcium
      phosphate fluoride paste (CPP-ACPF) associated with low level laser therapy (LLLT) in the
      symptomatology and on the quality of life of the individuals with dentin hypersensitivity in
      a randomized placebo-controlled clinical trial. Volunteers 18 to 50 years old with
      hypersensitive teeth were randomized into 4 groups: GPlacebo - positioning of the laser tip
      without light emission + placebo dentifrice; GCPPACPF - positioning of the laser tip without
      light emission + CPP-ACPF application; GLaser - laser tip positioning with light emission +
      placebo dentifrice; GLaserCPPACPF - positioning and light emission of the laser beam +
      CPP-ACPF.
GLaser received the laser application using the infrared light spectrum with wavelength of
      808 nm with its active AsGaAl medium in two points of the vestibular face of the
      hypersensitive teeth. At each point it was applied 60 J / cm², for 16 seconds. Three laser's
      sessions were applied with a time interval of 24 hours between them. GLaserCPPACPF first
      received the CPPACPF application and then the laser application according to the
      manufacturer's recommendations. Before initiating laser therapy, the equipment was calibrated
      with a tester (MMOptics Ltda®, Brazil).

      The GCPPACPF volunteers were submitted to the application of the CPPACPF'S containing tooth
      paste MI Paste Plus™ (Recaldent™, GC América, USA) on the vestibular surfaces of
      hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil)
      for 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece
      (500, Kavo, Germany) was used to scrub the desensitizing gel during 20 seconds on each tooth,
      according to the manufacturer's specifications. GPlacebo followed the same protocol used in
      GCPPACPF. In addition to the desensitizing treatments, all GCPPACPF and GPlacebo volunteers
      received the positioning of the laser tip to mimic the light emission produced in GLaser and
      GLaserCPPACPF. The noise emitted by the laser device was mimic through the sound reproduction
      of a smartphone application (HD Voice Recorder - iPhone 6s, Apple®, USA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Efficacy of treatment in dental sensitivity intensity change as assessed by VAS
time frame: 1 month
description: Self reported dentin sensitivity intensity before and after desensitizing treatment. Giving an score for each tooth by marking in the Visual Analogue Scale (VAS) from 0-10 (0-no pain and 10-pain as bad as it can be). With lower values representing a better outcome.
measure: Quality of life change
time frame: 1 month
description: Self reported dentin sensitivity intensity impact in the quality's of life before and after desensitizing treatment. By answering an specific questionnaire: Dentine Hypersensitivity Experience Questionnaire, measured in a likert scale from 7 to 1 (Where 7 is strongly agree and 1 is strongly disagree). With lower values representing a better outcome.
arm group label: GPlacebo
arm group type: Placebo Comparator
description: In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson & Johnson, Brazil) was applied to hypersensitive dentin. The GPlacebo volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.
arm group label: GCPPACPF
arm group type: Experimental
description: In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.
arm group label: GLaser
arm group type: Experimental
description: In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 3 sessions with a time interval of 24 hours between them.
arm group label: GLaserCPPACPF
arm group type: Experimental
description: In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.
intervention type: Other
intervention name: Placebo
description: In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson & Johnson, Brazil) was applied to hypersensitive dentin. The GPlacebo volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.
arm group label: GPlacebo
intervention type: Other
intervention name: CPPACPF
description: In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.
arm group label: GCPPACPF
intervention type: Other
intervention name: Laser
description: In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 3 sessions with a time interval of 24 hours between them.
arm group label: GLaser
intervention type: Other
intervention name: LaserCPPACPF
description: In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.
arm group label: GLaserCPPACPF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cecy M Silva, PhD
role: Principal Investigator
affiliation: clinical professor
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Para
investigator full name: Cecy Martins Silva
investigator title: PhD Clinical Professor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
sharing ipd: Undecided