<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/NCT03026725</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-OperDent-03-2016</org_study_id>
    <nct_id>NCT03026725</nct_id>
  </id_info>
  <brief_title>Effect of Tri Calcium Phosphate on Efficacy and Sensitivity With Vital Tooth Whitening Using 20% Carbamide Peroxide</brief_title>
  <official_title>Effect of Tri Calcium Phosphate Paste on Efficacy and Postoperative Sensitivity Associated With At-Home Vital Tooth Whitening Using 20% Carbamide Peroxide 'A Randomized Controlled Study'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium&#xD;
      phosphate containing pastes may affect the efficacy and postoperative sensitivity associated&#xD;
      with At-Home vital tooth whitening using 20% carbamide peroxide&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide&#xD;
      4h/day for a week, the sample will be divided into two groups : the experimental group will&#xD;
      apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment,&#xD;
      the control group will apply placebo paste 30 min/day after bleaching treatment,&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Change in Sensitivity Status</measure>
    <time_frame>at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application</time_frame>
    <description>using a visual analog scale (VAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Color Shade</measure>
    <time_frame>at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application</time_frame>
    <description>color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Tooth Sensitivity</condition>
  <arm_group>
    <arm_group_label>Tri-calcium Phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tri-calcium Phosphate</intervention_name>
    <description>A paste contains Tri Calcium Phosphate &amp; Fluoride</description>
    <arm_group_label>Tri-calcium Phosphate</arm_group_label>
    <other_name>( Clinpro™ Tooth Crème, 3M ESPE, USA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>paste manufactured to mimic Clinpro, without Tri Calcium Phosphate</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Good dental health&#xD;
&#xD;
          -  Six maxillary anterior teeth present and healthy with no restorations or carious&#xD;
             lesions&#xD;
&#xD;
          -  Teeth darker than Vita A2 shade&#xD;
&#xD;
          -  No history of teeth sensitivity&#xD;
&#xD;
          -  No use of a desensitizing agent or desensitizing toothpaste in the past three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active caries or periodontal disease&#xD;
&#xD;
          -  Allergies to bleaching agent or tray material&#xD;
&#xD;
          -  pregnancy and breastfeeding during the trial&#xD;
&#xD;
          -  tetracycline-stained teeth or fluoride or non-vital teeth&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Using tooth bleaching products during the last 3 years&#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>Oula Yassin, DDS, MSc,Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Damascus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Damascus University</name>
      <address>
        <city>Damascus</city>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Maghaireh GA, Alzraikat H, Guidoum A. Assessment of the effect of casein phosphopeptide-amorphous calcium phosphate on postoperative sensitivity associated with in-office vital tooth whitening. Oper Dent. 2014 May-Jun;39(3):239-47. doi: 10.2341/12-527-C. Epub 2013 Oct 22.</citation>
    <PMID>24147745</PMID>
  </reference>
  <reference>
    <citation>Loguercio AD, Tay LY, Herrera DR, Bauer J, Reis A. Effectiveness of nano-calcium phosphate paste on sensitivity during and after bleaching: a randomized clinical trial. Braz Oral Res. 2015;29:1-7. doi: 10.1590/1807-3107BOR-2015.vol29.0099. Epub 2015 Aug 21.</citation>
    <PMID>26313348</PMID>
  </reference>
  <reference>
    <citation>Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6. Erratum In: J Dent. 2017 Jul;62:98.</citation>
    <PMID>26159384</PMID>
  </reference>
  <reference>
    <citation>Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent. 2011 Sep-Oct;36(5):460-6. doi: 10.2341/10-159-C. Epub 2011 Aug 22.</citation>
    <PMID>21859318</PMID>
  </reference>
  <reference>
    <citation>Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.</citation>
    <PMID>22616927</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tooth sensitivity</keyword>
  <keyword>tri calcium phosphate</keyword>
  <keyword>at-home whitening</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT03026725
org study id: UDDS-OperDent-03-2016
nct id: NCT03026725
lead sponsor: 
has dmc: Yes
Teeth sensitivity is the most popular symptom when using At-Home tooth whitening. Tri calcium
      phosphate containing pastes may affect the efficacy and postoperative sensitivity associated
      with At-Home vital tooth whitening using 20% carbamide peroxide
Subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide
      4h/day for a week, the sample will be divided into two groups : the experimental group will
      apply tri calcium phosphate containing paste(Clinpro) 30 min/day after bleaching treatment,
      the control group will apply placebo paste 30 min/day after bleaching treatment,
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in Sensitivity Status
time frame: at (1) 24 hours following application, (2) at 48 hours post-application, (3) at 72 hours post-application and (4) at seven days following application
description: using a visual analog scale (VAS)
measure: Change in Color Shade
time frame: at (1) 72 hours following application , (2) one week following application, (3) two weeks following application, and (4) one month following application
description: color shade change will be detected; using Vita Easy Shadeِ Advance 4.0.
arm group label: Tri-calcium Phosphate
arm group type: Experimental
description: clinpro tooth creme, i.e. Tri-calcium Phosphate, for 30 min/day after bleaching 4h with carbamide peroxide 20%
arm group label: Placebo
arm group type: Placebo Comparator
description: a placebo creme will be applied for 30 min/day after bleaching 4h with carbamide peroxide 20%
intervention type: Other
intervention name: Tri-calcium Phosphate
description: A paste contains Tri Calcium Phosphate & Fluoride
arm group label: Tri-calcium Phosphate
other name: ( Clinpro™ Tooth Crème, 3M ESPE, USA
intervention type: Other
intervention name: Placebo
description: paste manufactured to mimic Clinpro, without Tri Calcium Phosphate
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Oula Yassin, DDS, MSc,Phd
role: Principal Investigator
affiliation: Damascus University
facility: 
country: Syrian Arab Republic
citation: Maghaireh GA, Alzraikat H, Guidoum A. Assessment of the effect of casein phosphopeptide-amorphous calcium phosphate on postoperative sensitivity associated with in-office vital tooth whitening. Oper Dent. 2014 May-Jun;39(3):239-47. doi: 10.2341/12-527-C. Epub 2013 Oct 22.
PMID: 24147745
citation: Loguercio AD, Tay LY, Herrera DR, Bauer J, Reis A. Effectiveness of nano-calcium phosphate paste on sensitivity during and after bleaching: a randomized clinical trial. Braz Oral Res. 2015;29:1-7. doi: 10.1590/1807-3107BOR-2015.vol29.0099. Epub 2015 Aug 21.
PMID: 26313348
citation: Pintado-Palomino K, Peitl Filho O, Zanotto ED, Tirapelli C. A clinical, randomized, controlled study on the use of desensitizing agents during tooth bleaching. J Dent. 2015 Sep;43(9):1099-1105. doi: 10.1016/j.jdent.2015.07.002. Epub 2015 Jul 6. Erratum In: J Dent. 2017 Jul;62:98.
PMID: 26159384
citation: Dawson PF, Sharif MO, Smith AB, Brunton PA. A clinical study comparing the efficacy and sensitivity of home vs combined whitening. Oper Dent. 2011 Sep-Oct;36(5):460-6. doi: 10.2341/10-159-C. Epub 2011 Aug 22.
PMID: 21859318
citation: Basting RT, Amaral FL, Franca FM, Florio FM. Clinical comparative study of the effectiveness of and tooth sensitivity to 10% and 20% carbamide peroxide home-use and 35% and 38% hydrogen peroxide in-office bleaching materials containing desensitizing agents. Oper Dent. 2012 Sep-Oct;37(5):464-73. doi: 10.2341/11-337-C. Epub 2012 May 18.
PMID: 22616927
responsible party type: Sponsor
mesh term: Dentin Sensitivity
mesh term: Hypersensitivity
mesh term: Calcium
sharing ipd: No