xml: <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/NCT06035588</url>
    </required_header>
    <id_info>
      <org_study_id>URJC University</org_study_id>
      <nct_id>NCT06035588</nct_id>
    </id_info>
    <brief_title>Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days</brief_title>
    <official_title>Efficacy in the Reduction of Hypersensitivity During Home Whitening With 16% Carbamide Peroxide Applied on Alternate Days: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidad Rey Juan Carlos</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidad Rey Juan Carlos</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 concentration of 16% carbamide peroxide is the highest concentration that European&#xD;
        regulations allow for use in home whitening (Council directive 2011/84/EU). This&#xD;
        concentration allows for faster results, but instead patients may suffer more frequently from&#xD;
        dental sensitivity. The most commonly described side effect of all whitening procedures is&#xD;
        the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this&#xD;
        adverse effect.&#xD;
  &#xD;
        The objective of the study is to clinically evaluate the difference in dental&#xD;
        hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in&#xD;
        a tray for two hours daily applied daily or every other day for three weeks.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a&#xD;
        total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching&#xD;
        procedure will be performed every other day or daily. In the upper arch, the teeth to be&#xD;
        whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and&#xD;
        satisfaction will be carried out in the upper and lower arch. The color will be recorded&#xD;
        before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade&#xD;
        assessment using the subjective method will be recorded with the Vita Classical color scale&#xD;
        (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER&#xD;
        scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade&#xD;
        spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the&#xD;
        CIEL*a*b* system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">June 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 27, 2023</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>Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>The present study presents blinding of both the evaluator and the person who will carry out the statistical analysis, and therefore double-blind. The evaluators are considered blind in this study because they do not know the randomization of the patients, being a blind study. The operator and patients know the groups in which they are assigned, due to the delivery and placement of the splints.&#xD;
  A block randomization of the treatment applied to the patients will be carried out, to ensure that the sample size is similar in both groups. The operator will open an envelope for the group's allocation. The assignment of the groups will be carried out using opaque, sealed and sequentially numbered envelopes. The operator will open the envelope when the splints are delivered, and will give the pertinent explanations to the patient. Data will be collected from each patient that may influence treatment results such as age, sex, initial color, systemic pathologies and pharmacological treatments.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Dental Sensitivity</measure>
      <time_frame>3 weeks</time_frame>
      <description>The objective of the study is to clinically evaluate the appearance of dental sensitivity produced by the home dental whitening treatment using 16% carbamide peroxide applied in a tray for two hours daily each day or using it on alternate days for three weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>whitening efficacy</measure>
      <time_frame>1 month</time_frame>
      <description>To assess whether the efficacy of the 16% carbamide peroxide whitening treatment described above applied every other day is the same as when used every day or is there a difference in whitening efficacy. This will be determined instrumentally with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB, CIEDE2000 system and the whiteness index.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Gingival irritation</measure>
      <time_frame>3 weeks</time_frame>
      <description>To compare the existence of gingival irritation using the Visual Analog Scale after the application of bleaching every two days with 16% carbamide peroxide, compared to the daily application.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient's oral quality of life</measure>
      <time_frame>1 month</time_frame>
      <description>To assess the impact on the patient's oral quality of life (OHIP-14) in terms of treatment results using a questionnaire, after applying home whitening with 16% carbamide peroxide every other day, instead of applying it daily.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Dental Hypersensitivity</condition>
    <condition>Teeth Whitening</condition>
    <arm_group>
      <arm_group_label>Daily whitening</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alternate whitening</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Daily whitening</intervention_name>
      <description>Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.</description>
      <arm_group_label>Daily whitening</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Alternate whitening</intervention_name>
      <description>Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.</description>
      <arm_group_label>Alternate whitening</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years.&#xD;
  &#xD;
            -  Patients with vital teeth without restorations, single crowns, implants and/or bridges&#xD;
               at the level of the anterior teeth.&#xD;
  &#xD;
            -  Absence of cavities in the teeth to be whitened.&#xD;
  &#xD;
            -  Patients with satisfactory oral hygiene and periodontally healthy, who are not&#xD;
               undergoing periodontal maintenance and who do not use chlorhexidine mouthwashes.&#xD;
               Patients with recessions without presenting sensitivity will be included.&#xD;
  &#xD;
            -  Absence of sensitivity, measured with the application of air with the dental team's&#xD;
               syringe.&#xD;
  &#xD;
            -  Patients whose canines have at least an A2-A3 shade (VITA Classic® Guide).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have previously undergone whitening (less than 5 years).&#xD;
  &#xD;
            -  Patients undergoing orthodontic treatment.&#xD;
  &#xD;
            -  Patients with white spots or alterations in the development of enamel or with stains.&#xD;
  &#xD;
            -  Patients with a history of trauma to anterior teeth.&#xD;
  &#xD;
            -  Patients who require internal whitening.&#xD;
  &#xD;
            -  Smokers.&#xD;
  &#xD;
            -  Pregnant or lactating.&#xD;
  &#xD;
            -  Patients with allergies to any whitening component.&#xD;
  &#xD;
            -  Patients presenting alterations of the oral mucosa (desquamative gingivitis, oral&#xD;
               lichen planus, leukoplakia, etc.).&#xD;
  &#xD;
            -  Patients with medical conditions considered by the researchers that may compromise the&#xD;
               study or the individual safety of the patient.&#xD;
  &#xD;
            -  Patients with poor oral hygiene.&#xD;
  &#xD;
            -  Patients with previous hypersensitivity.&#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_contact>
      <last_name>ISABEL GIRALDEZ DE LUIS, Lecturer</last_name>
      <phone>669119781</phone>
      <email>isabel.giraldez@urjc.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>Isabel Giraldez de Luis</name>
        <address>
          <city>Alcorcón</city>
          <state>Madrid</state>
          <zip>28922</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>ISABEL GIRALDEZ DE LUIS, Lecturer</last_name>
        <phone>+34669119781</phone>
        <email>isabel.giraldez@urjc.es</email>
      </contact>
      <investigator>
        <last_name>LAURA CEBALLOS GARCÍA, Proffesor</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>VICTORIA FUENTES FUENTES, SeniorLecturer</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>BELÉN SUCH, PostGraduate</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>ISABEL GIRÁLDEZ DE LUIS, Lecturer</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.</citation>
      <PMID>20884923</PMID>
    </reference>
    <reference>
      <citation>Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.</citation>
      <PMID>31335161</PMID>
    </reference>
    <reference>
      <citation>de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L.</citation>
      <PMID>29949477</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidad Rey Juan Carlos</investigator_affiliation>
      <investigator_full_name>Isabel Giráldez de Luis</investigator_full_name>
      <investigator_title>Lecturer of Department for Conservative Dentistry at Rey Juan Carlos University</investigator_title>
    </responsible_party>
    <keyword>bleaching</keyword>
    <keyword>hipersensitivity</keyword>
    <keyword>whitening</keyword>
    <keyword>at-home</keyword>
    <keyword>carbamide</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The results obtained will only be shared once they have been published in an impact journal.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035588
  org study id: URJC University
  nct id: NCT06035588
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The concentration of 16% carbamide peroxide is the highest concentration that European
        regulations allow for use in home whitening (Council directive 2011/84/EU). This
        concentration allows for faster results, but instead patients may suffer more frequently from
        dental sensitivity. The most commonly described side effect of all whitening procedures is
        the appearance of dentin hypersensitivity, hence the efforts to counteract or overcome this
        adverse effect.
  
        The objective of the study is to clinically evaluate the difference in dental
        hypersensitivity produced by home dental whitening treatment using 16% carbamide peroxide in
        a tray for two hours daily applied daily or every other day for three weeks.
  Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a
        total of 3 weeks of whitening procedure. Depending on the randomization, the bleaching
        procedure will be performed every other day or daily. In the upper arch, the teeth to be
        whitened will be from 15 to 25. The evaluations of efficacy, dental sensitivity and
        satisfaction will be carried out in the upper and lower arch. The color will be recorded
        before, weekly for 1 month, 6 months and 12 months after finishing the treatment. Shade
        assessment using the subjective method will be recorded with the Vita Classical color scale
        (Vita Zahnfabrik, Bad Säckingen, Germany), it will also be determined with the Vita 3D-MASTER
        scale (Vita Zahnfabrik, Bad Säckingen, Germany). For objective evaluation, the Vita Easyshade
        spectrophotometer (Vita Zahnfabrik, Bad Säckingen, Germany) will be used, according to the
        CIEL*a*b* system.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Each volunteer will be given 3 syringes of 16% carbamide peroxide bleaching gel to use on the splint. Volunteers will be instructed to use the whitening gel once a day for 2 hours, completing a total of 3 weeks of whitening procedure. Depending on the randomization, the whitening procedure will be performed on alternate days or daily. In the upper arch, the teeth to be whitened will be from 15 to 25 and in the lower one from 35 to 45.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: The present study presents blinding of both the evaluator and the person who will carry out the statistical analysis, and therefore double-blind. The evaluators are considered blind in this study because they do not know the randomization of the patients, being a blind study. The operator and patients know the groups in which they are assigned, due to the delivery and placement of the splints.
  A block randomization of the treatment applied to the patients will be carried out, to ensure that the sample size is similar in both groups. The operator will open an envelope for the group's allocation. The assignment of the groups will be carried out using opaque, sealed and sequentially numbered envelopes. The operator will open the envelope when the splints are delivered, and will give the pertinent explanations to the patient. Data will be collected from each patient that may influence treatment results such as age, sex, initial color, systemic pathologies and pharmacological treatments.
  measure: Dental Sensitivity
  time frame: 3 weeks
  description: The objective of the study is to clinically evaluate the appearance of dental sensitivity produced by the home dental whitening treatment using 16% carbamide peroxide applied in a tray for two hours daily each day or using it on alternate days for three weeks.
  measure: whitening efficacy
  time frame: 1 month
  description: To assess whether the efficacy of the 16% carbamide peroxide whitening treatment described above applied every other day is the same as when used every day or is there a difference in whitening efficacy. This will be determined instrumentally with the Vita EasyShade V® spectrophotometer, based on the CIEL*a*b* system, according to the CIELAB, CIEDE2000 system and the whiteness index.
  measure: Gingival irritation
  time frame: 3 weeks
  description: To compare the existence of gingival irritation using the Visual Analog Scale after the application of bleaching every two days with 16% carbamide peroxide, compared to the daily application.
  measure: Patient's oral quality of life
  time frame: 1 month
  description: To assess the impact on the patient's oral quality of life (OHIP-14) in terms of treatment results using a questionnaire, after applying home whitening with 16% carbamide peroxide every other day, instead of applying it daily.
  arm group label: Daily whitening
  arm group type: Active Comparator
  description: Volunteers should whiten daily with a whitening tray from 15 to 25 and 35 to 45 for 2 hours. This procedure will last 3 weeks.
  arm group label: Alternate whitening
  arm group type: Experimental
  description: Volunteers will bleach for 3 weeks with 16% carbamide peroxide, alternating one rest day for each placement day. They will wear a whitening tray from 15 to 25 and from 35 to 45 for 2 hours.
  intervention type: Other
  intervention name: Daily whitening
  description: Daily application of a 16% carbamide peroxide bleaching gel in volunteers without sensitivity.
  arm group label: Daily whitening
  intervention type: Other
  intervention name: Alternate whitening
  description: Volunteers will apply the whitening gel at 16% carbamide peroxide, alternating a rest day with an application day. Patients should not be sensitive before starting the study.
  arm group label: Alternate whitening
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: ISABEL GIRALDEZ DE LUIS, Lecturer
  phone: 669119781
  email: isabel.giraldez@urjc.es
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Spain
  citation: Cardoso PC, Reis A, Loguercio A, Vieira LC, Baratieri LN. Clinical effectiveness and tooth sensitivity associated with different bleaching times for a 10 percent carbamide peroxide gel. J Am Dent Assoc. 2010 Oct;141(10):1213-20. doi: 10.14219/jada.archive.2010.0048.
  PMID: 20884923
  citation: Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.
  PMID: 31335161
  citation: de Geus JL, Wambier LM, Boing TF, Loguercio AD, Reis A. At-home Bleaching With 10% vs More Concentrated Carbamide Peroxide Gels: A Systematic Review and Meta-analysis. Oper Dent. 2018 Jul/Aug;43(4):E210-E222. doi: 10.2341/17-222-L.
  PMID: 29949477
  responsible party type: Principal Investigator
  investigator affiliation: Universidad Rey Juan Carlos
  investigator full name: Isabel Giráldez de Luis
  investigator title: Lecturer of Department for Conservative Dentistry at Rey Juan Carlos University
  mesh term: Hypersensitivity
  sharing ipd: No
  ipd description: The results obtained will only be shared once they have been published in an impact journal.