<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/NCT04407702</url>
  </required_header>
  <id_info>
    <org_study_id>Hypersensitivity</org_study_id>
    <nct_id>NCT04407702</nct_id>
  </id_info>
  <brief_title>Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization</brief_title>
  <official_title>Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin&#xD;
      when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the&#xD;
      occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and&#xD;
      connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of&#xD;
      a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The&#xD;
      control of tooth sensitivity is fundamental to the successful treatment of MIH.&#xD;
&#xD;
      Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the&#xD;
      effectiveness of different protocols for the control of DH in patients with teeth affected by&#xD;
      MIH.&#xD;
&#xD;
      Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four&#xD;
      groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be&#xD;
      sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser&#xD;
      (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In&#xD;
      Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be&#xD;
      evaluated 15 min after the application of the treatments and the patients will be reevaluated&#xD;
      one week, one month, three months and six months after the treatments.&#xD;
&#xD;
      Discussion: This study will enable the determination of differences in the effectiveness of&#xD;
      the proposed treatments as well as differences among the evaluation times for each proposed&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2021</start_date>
  <completion_date type="Anticipated">December 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <masking_description>All volunteers and the evaluator of the degree of sensitivity will be blinded to the allocation. The researcher in charge of applying the products will not be blinded due to the different forms of clinical manipulation of the products.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain evaluated through a Visual Analog Scale (VAS)</measure>
    <time_frame>Baseline, one week, one month, three months and six months after the final treatment session.</time_frame>
    <description>The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Dentin Sensitivity</condition>
  <condition>Molar Incisor Hypomineralization</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sealant Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Level Laser Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Level Laser + Sealant Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hygiene Instructions</intervention_name>
    <description>Two weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Low Level Laser + Sealant Group</arm_group_label>
    <arm_group_label>Low-Level Laser Group</arm_group_label>
    <arm_group_label>Sealant Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sealant application</intervention_name>
    <description>The teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated.</description>
    <arm_group_label>Low Level Laser + Sealant Group</arm_group_label>
    <arm_group_label>Sealant Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Low-level Laser</intervention_name>
    <description>Irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions.</description>
    <arm_group_label>Low Level Laser + Sealant Group</arm_group_label>
    <arm_group_label>Low-Level Laser Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 35 years;&#xD;
&#xD;
          -  Good overall health;&#xD;
&#xD;
          -  At least one tooth with MIH and DH reported in the cervical region with sensitivity&#xD;
             equal to or greater than 4 on the VAS.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active caries or defective restorations on the tooth to be analyzed;&#xD;
&#xD;
          -  Sufficient dentin loss that requires restorative treatment or periodontal surgery;&#xD;
&#xD;
          -  Having undergone any professional desensitizing treatment in the previous six months;&#xD;
&#xD;
          -  Having used a desensitizing paste in the previous three months;&#xD;
&#xD;
          -  Use of anti-inflammatory drugs or analgesics at the time of recruitment;&#xD;
&#xD;
          -  Currently pregnant or nursing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>November 25, 2020</last_update_submitted>
  <last_update_submitted_qc>November 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Molar Hypomineralization</mesh_term>
    <mesh_term>Dental Enamel Hypoplasia</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets (Excel spreadsheets) generated from this protocol will be available with the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) at a reasonable request. However, reuse of this data will not be allowed for people who are not authors of this paper.</ipd_description>
  </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/NCT04407702
org study id: Hypersensitivity
nct id: NCT04407702
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin
      when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the
      occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and
      connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of
      a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The
      control of tooth sensitivity is fundamental to the successful treatment of MIH.

      Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the
      effectiveness of different protocols for the control of DH in patients with teeth affected by
      MIH.

      Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four
      groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be
      sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser
      (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In
      Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be
      evaluated 15 min after the application of the treatments and the patients will be reevaluated
      one week, one month, three months and six months after the treatments.

      Discussion: This study will enable the determination of differences in the effectiveness of
      the proposed treatments as well as differences among the evaluation times for each proposed
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: All volunteers and the evaluator of the degree of sensitivity will be blinded to the allocation. The researcher in charge of applying the products will not be blinded due to the different forms of clinical manipulation of the products.
measure: Change in pain evaluated through a Visual Analog Scale (VAS)
time frame: Baseline, one week, one month, three months and six months after the final treatment session.
description: The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.
arm group label: Control Group
arm group type: Experimental
description: The volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light.
arm group label: Sealant Group
arm group type: Experimental
description: The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.
arm group label: Low-Level Laser Group
arm group type: Experimental
description: The volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation.
arm group label: Low Level Laser + Sealant Group
arm group type: Experimental
description: The volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group.
intervention type: Other
intervention name: Hygiene Instructions
description: Two weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment.
arm group label: Control Group
arm group label: Low Level Laser + Sealant Group
arm group label: Low-Level Laser Group
arm group label: Sealant Group
intervention type: Procedure
intervention name: Sealant application
description: The teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated.
arm group label: Low Level Laser + Sealant Group
arm group label: Sealant Group
intervention type: Radiation
intervention name: Low-level Laser
description: Irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions.
arm group label: Low Level Laser + Sealant Group
arm group label: Low-Level Laser Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Principal Investigator
mesh term: Dentin Sensitivity
mesh term: Molar Hypomineralization
mesh term: Dental Enamel Hypoplasia
mesh term: Hypersensitivity
sharing ipd: Yes
ipd description: The datasets (Excel spreadsheets) generated from this protocol will be available with the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) at a reasonable request. However, reuse of this data will not be allowed for people who are not authors of this paper.