<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/NCT03237793</url>
  </required_header>
  <id_info>
    <org_study_id>02_D012_45912</org_study_id>
    <nct_id>NCT03237793</nct_id>
  </id_info>
  <brief_title>Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth</brief_title>
  <official_title>Treatment of Hypersensitivity Using Diode Laser and Potassium Nitrate Desensitising Agent- a Comparison of Treatment Effects on Fluorosed and Non-fluorosed Teeth- an in Vivo Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Krishnadevaraya College of Dental Sciences &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Krishnadevaraya College of Dental Sciences &amp; Hospital</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>
      The present study was designed as a randomised controlled clinical trial which was unicenter,&#xD;
      double-blinded, parallel designed study, according to the Consolidated Standards of Reporting&#xD;
      Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College&#xD;
      of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of&#xD;
      dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years.&#xD;
      The subjects interested in participating were explained in detail the treatment protocol. A&#xD;
      verbal consent as well as a written informed consent was obtained from each patient Treatment&#xD;
      of dentinal hypersensitivity with a combination of diode laser and potassium nitrate&#xD;
      desensitising agent was considered as the test group and this was compared with diode lasers&#xD;
      alone and desensitising agent alone as the positive control groups. The study was conducted&#xD;
      in full accordance with the declared ethical principles (World Medical Association&#xD;
      Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review&#xD;
      board of Krishnadevaraya College of Dental Science and Hospital, under the registration&#xD;
      number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>A unified stratified randomization, double blind controlled parallel designed was the type generated the allocation sequence. A skilled assistant enrolled the participants and assigned the participants to interventions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in hypersensitivity</measure>
    <time_frame>30 minutes</time_frame>
    <description>The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>use of diode laser in reducing hypersensitivity</measure>
    <time_frame>30 mins</time_frame>
    <description>Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of desensitising agent alone</measure>
    <time_frame>30 minutes</time_frame>
    <description>Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>combination of densensitising agent and diode laser</measure>
    <time_frame>30 minutes</time_frame>
    <description>3. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Fluorosis, Dental</condition>
  <condition>Non-Fluoride Enamel Opacities</condition>
  <condition>Dentin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Fluorosed Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal**) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Flourosed Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment. (n=15</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluorosed Group</intervention_name>
    <description>A single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned</description>
    <arm_group_label>Fluorosed Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non Flourosed Group</intervention_name>
    <description>A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.</description>
    <arm_group_label>Non Flourosed Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e.&#xD;
             cold water testing using ice cold water (Trowbridge et al., 1980),&#xD;
&#xD;
               -  Air blow test (Coleman and Kinderknecht, 2000),&#xD;
&#xD;
               -  Electric tactile stimulation test (Camps and Pashley, 2003),&#xD;
&#xD;
               -  Patients presenting with non-carious cervical lesions in the enamel (Loomba et&#xD;
                  al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by&#xD;
                  clinical examination, healthy non fluorosed teeth, which was confirmed by&#xD;
                  clinical examination (Dean, 1934).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The following were set as the exclusion criteria;&#xD;
&#xD;
               -  Patients undergoing any form of restorative endodontic,&#xD;
&#xD;
               -  Orthodontic treatment or crown restorations,&#xD;
&#xD;
               -  Local defects including caries and fractures,&#xD;
&#xD;
               -  Presence of any systemic diseases,&#xD;
&#xD;
               -  Acute pain conditions (like apical periodontitis, periapical abscess),&#xD;
&#xD;
               -  Presence of periodontal disease or a history of periodontal treatment in last 6&#xD;
                  months,&#xD;
&#xD;
               -  Usage of desensitising toothpaste or mouth rinse in the last 4 weeks,&#xD;
&#xD;
               -  Patients allergic to ingredients used in the study product,&#xD;
&#xD;
               -  Teeth with intrinsic stains caused by other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rashmi Paramashivaiah, MDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Krishnadevaraya college of dental sciences</affiliation>
  </overall_official>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dentin Sensitivity</mesh_term>
    <mesh_term>Fluorosis, Dental</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT03237793
org study id: 02_D012_45912
nct id: NCT03237793
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study was designed as a randomised controlled clinical trial which was unicenter,
      double-blinded, parallel designed study, according to the Consolidated Standards of Reporting
      Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.
90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College
      of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of
      dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years.
      The subjects interested in participating were explained in detail the treatment protocol. A
      verbal consent as well as a written informed consent was obtained from each patient Treatment
      of dentinal hypersensitivity with a combination of diode laser and potassium nitrate
      desensitising agent was considered as the test group and this was compared with diode lasers
      alone and desensitising agent alone as the positive control groups. The study was conducted
      in full accordance with the declared ethical principles (World Medical Association
      Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review
      board of Krishnadevaraya College of Dental Science and Hospital, under the registration
      number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: A unified stratified randomization, double blind controlled parallel designed was the type generated the allocation sequence. A skilled assistant enrolled the participants and assigned the participants to interventions.
measure: Reduction in hypersensitivity
time frame: 30 minutes
description: The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.
measure: use of diode laser in reducing hypersensitivity
time frame: 30 mins
description: Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.
measure: use of desensitising agent alone
time frame: 30 minutes
description: Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing
measure: combination of densensitising agent and diode laser
time frame: 30 minutes
description: 3. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.
arm group label: Fluorosed Group
arm group type: Active Comparator
description: 45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal**) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15)
arm group label: Non Flourosed Group
arm group type: Placebo Comparator
description: 45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment. (n=15
intervention type: Procedure
intervention name: Fluorosed Group
description: A single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned
arm group label: Fluorosed Group
intervention type: Procedure
intervention name: Non Flourosed Group
description: A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.
arm group label: Non Flourosed Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rashmi Paramashivaiah, MDS
role: Principal Investigator
affiliation: Krishnadevaraya college of dental sciences
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Fluorosis, Dental
mesh term: Hypersensitivity