<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/NCT03287011</url>
  </required_header>
  <id_info>
    <org_study_id>SUKD</org_study_id>
    <nct_id>NCT03287011</nct_id>
  </id_info>
  <brief_title>Efficacy of a Plaque Disclosing Toothpaste on Home Oral Hygiene Procedures</brief_title>
  <official_title>Efficacy of Shoplaq® Disclosing Toothpaste in Removing Dental Plaque: A Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Segi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Segi University</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>
      Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases&#xD;
      such as demineralization, dental caries, gingivitis, and periodontitis.&#xD;
&#xD;
      Tooth brushing and flossing have been the cornerstone of oral hygiene and health. However,&#xD;
      the high incidence and prevalence of gum problems in both the developed and developing world&#xD;
      show these mechanical routines are not enough. Furthermore, many patients find it difficult&#xD;
      to comply with this daily regime of brushing and flossing. Consistent with problems&#xD;
      associated with maintaining oral health, periodontal disease is one of the most common&#xD;
      chronic infections in adults. According to Philstrom, et al. up to 90% of the world's&#xD;
      population has or will suffer from periodontal disease.Thus, the maintenance of an adequate&#xD;
      level of plaque control by the individual through his or her daily oral hygiene is vital to&#xD;
      prevent and control periodontal disease. Studies demonstrate that poor oral hygiene is&#xD;
      widespread with about 60% of plaque found on the surfaces of the teeth after brushing. This&#xD;
      may be due to the lack of manipulative skills, lack of motivation and compliance.Hence,&#xD;
      increasing education and improving brushing technique by improving oral hygiene products is&#xD;
      one way to enhance plaque removal in everyday brushing. The ability to see plaque while&#xD;
      brushing will enhance patient's awareness and encourage them to be more thorough when&#xD;
      performing oral hygiene.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases&#xD;
      such as demineralization, dental caries, gingivitis, and periodontitis. 1 Thus, the&#xD;
      maintenance of an adequate level of plaque control by the individual through his or her daily&#xD;
      oral hygiene is vital to prevent and control periodontal disease which can result in tooth&#xD;
      mobility and tooth loss. 2 Tooth brushing and flossing have been the cornerstone of oral&#xD;
      hygiene and health.2 However, the high incidence and prevalence of gum problems in both the&#xD;
      developed and developing countries show these mechanical routines are not enough. 1 Studies&#xD;
      demonstrate that poor oral hygiene is widespread with about 60% of plaque found on the&#xD;
      surfaces of the teeth after brushing.3 Furthermore, many patients find it difficult to comply&#xD;
      with this daily regimen of brushing and flossing. 2 This may be due to the lack of&#xD;
      manipulative skills, lack of motivation and compliance. 2 According to an overview of the&#xD;
      challenges in dental public health in Malaysia by Allan Kah, he stated that only 26% of&#xD;
      15-19-year-old and only 5% of 35-44-year-olds have been reported to have healthy periodontal&#xD;
      tissues. 4 Studies such as the one done by Deliargyris, showed that periodontal disease was&#xD;
      associated with the enhanced systemic inflammatory response with various mediators. Thus, it&#xD;
      may contribute to systemic diseases. For example, periodontal disease has been linked to&#xD;
      atherosclerosis via an increased level of serum C-reactive protein, a marker for inflammation&#xD;
      and a high-risk factor for coronary artery disease.5 Hence, there is a need to increase&#xD;
      education and improve brushing technique. This can be done by improving oral hygiene products&#xD;
      by incorporating a plaque disclosing dye in the toothpaste.1 The ability to see plaque while&#xD;
      brushing will enhance patient's awareness and encourage them to be more thorough when&#xD;
      performing oral hygiene. 1 Previous studies done by the Department of Orthodontics,&#xD;
      University of Illinois have shown that using a toothpaste with a plaque indicating dye such&#xD;
      as PlaqueHD® to disclose plaque while brushing resulted in more than four times as much&#xD;
      plaque elimination between visits (51.3% reduction, p = 0.015) than participants using only&#xD;
      the placebo toothpaste (8.3% reduction, p=0.189). 1 However, one of the limitations of the&#xD;
      product used in that study is the high cost of the toothpaste and the difficulty in obtaining&#xD;
      the toothpaste in South East Asia.Hence, the present study aims to assess the efficacy of a&#xD;
      plaque disclosing toothpaste that is easily available and affordable which was developed with&#xD;
      the Health Promotion Board of Singapore, named Shoplaq® in reducing dental plaque.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 30, 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>
    <intervention_model_description>interventional preventive trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>Toothpaste tubes will be masked so the care provider would not know which tube he/she allocating to the participants as well the outcome assessor would be masked from both groups ( test and control) so data is assessed unbiased.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Plaque removal efficacy of a disclosing toothpaste</measure>
    <time_frame>from Baseline to 1 year</time_frame>
    <description>Silness and Loe plaque index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste</measure>
    <time_frame>from Baseline to 1 year</time_frame>
    <description>Loe and Silness gingival index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>digital image analysis</measure>
    <time_frame>from Baseline to 1 year</time_frame>
    <description>MATLAB software for digital image analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse effects</measure>
    <time_frame>baseline to 1 year</time_frame>
    <description>To record any side effects or adverse effects of the toothpaste seen by the patient or&#xD;
clinician. soft tissue changes, taste alteration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient perceived outcomes</measure>
    <time_frame>baseline to 1 year</time_frame>
    <description>self-administered questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chronic Gingivitis, Plaque Induced</condition>
  <arm_group>
    <arm_group_label>Control tooth paste</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>controlled fluoridated toothpaste will be provided for brushing to both the groups initially</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoplaque tooth paste</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shoplaq toothpaste</intervention_name>
    <description>ACTIVE INGREDIENT Sodium Monofluorophosphate 1000 PPM INGREDIENTS Precipitated Calcium Carbonate, Sorbitol, Glycerin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Sodium Benzoate, DM Water, Colour CI-45410, Holy Basil Oil, Neem Oil, Citrus Oil, Thymol Oi, Clove Oil, Piper Betel Leaf Oil, Tea Tree Oil, Eucalyptus Oil, Peppermint Oil, Spearmint Oil.&#xD;
Dye containing tooth paste for disclosing plaque and efficient brushing for better oral health.</description>
    <arm_group_label>Shoplaque tooth paste</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Colgate toothpaste</intervention_name>
    <description>fluoridated</description>
    <arm_group_label>Control tooth paste</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Students of SEGi must be aged 18 to 25 years with chronic generalized gingivitis 2)&#xD;
&#xD;
          -  With no known systemic illness.&#xD;
&#xD;
          -  Minimum of 12 anterior teeth present (canine to canine) in both upper and lower arches&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who are pregnant or nursing.&#xD;
&#xD;
          -  A dental student or faculty or dental staff member.&#xD;
&#xD;
          -  Who have been on antibiotics within two weeks prior to examination.&#xD;
&#xD;
          -  Having dry mouth syndrome or significant food allergies.&#xD;
&#xD;
          -  Have undergone any dental procedures or oral prophylaxis within 30 days prior to&#xD;
             testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Avita Rath</name>
      <address>
        <city>Petaling Jaya</city>
        <state>Selangor</state>
        <zip>47810</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Avita Rath, MDS</last_name>
      <phone>60109677452</phone>
      <email>avitashanti@segi.edu.my</email>
    </contact>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 16, 2017</last_update_submitted>
  <last_update_submitted_qc>September 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Segi University</investigator_affiliation>
    <investigator_full_name>Avita Rath</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>dental plaque</keyword>
  <keyword>tooth pastes</keyword>
  <keyword>oral hygiene</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingivitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>article with study description and result</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>July 2018</ipd_time_frame>
    <ipd_access_criteria>through journal publication</ipd_access_criteria>
  </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/NCT03287011
org study id: SUKD
nct id: NCT03287011
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases
      such as demineralization, dental caries, gingivitis, and periodontitis.

      Tooth brushing and flossing have been the cornerstone of oral hygiene and health. However,
      the high incidence and prevalence of gum problems in both the developed and developing world
      show these mechanical routines are not enough. Furthermore, many patients find it difficult
      to comply with this daily regime of brushing and flossing. Consistent with problems
      associated with maintaining oral health, periodontal disease is one of the most common
      chronic infections in adults. According to Philstrom, et al. up to 90% of the world's
      population has or will suffer from periodontal disease.Thus, the maintenance of an adequate
      level of plaque control by the individual through his or her daily oral hygiene is vital to
      prevent and control periodontal disease. Studies demonstrate that poor oral hygiene is
      widespread with about 60% of plaque found on the surfaces of the teeth after brushing. This
      may be due to the lack of manipulative skills, lack of motivation and compliance.Hence,
      increasing education and improving brushing technique by improving oral hygiene products is
      one way to enhance plaque removal in everyday brushing. The ability to see plaque while
      brushing will enhance patient's awareness and encourage them to be more thorough when
      performing oral hygiene.
Plaque accumulation on tooth and gingival surfaces is a causative factor for oral diseases
      such as demineralization, dental caries, gingivitis, and periodontitis. 1 Thus, the
      maintenance of an adequate level of plaque control by the individual through his or her daily
      oral hygiene is vital to prevent and control periodontal disease which can result in tooth
      mobility and tooth loss. 2 Tooth brushing and flossing have been the cornerstone of oral
      hygiene and health.2 However, the high incidence and prevalence of gum problems in both the
      developed and developing countries show these mechanical routines are not enough. 1 Studies
      demonstrate that poor oral hygiene is widespread with about 60% of plaque found on the
      surfaces of the teeth after brushing.3 Furthermore, many patients find it difficult to comply
      with this daily regimen of brushing and flossing. 2 This may be due to the lack of
      manipulative skills, lack of motivation and compliance. 2 According to an overview of the
      challenges in dental public health in Malaysia by Allan Kah, he stated that only 26% of
      15-19-year-old and only 5% of 35-44-year-olds have been reported to have healthy periodontal
      tissues. 4 Studies such as the one done by Deliargyris, showed that periodontal disease was
      associated with the enhanced systemic inflammatory response with various mediators. Thus, it
      may contribute to systemic diseases. For example, periodontal disease has been linked to
      atherosclerosis via an increased level of serum C-reactive protein, a marker for inflammation
      and a high-risk factor for coronary artery disease.5 Hence, there is a need to increase
      education and improve brushing technique. This can be done by improving oral hygiene products
      by incorporating a plaque disclosing dye in the toothpaste.1 The ability to see plaque while
      brushing will enhance patient's awareness and encourage them to be more thorough when
      performing oral hygiene. 1 Previous studies done by the Department of Orthodontics,
      University of Illinois have shown that using a toothpaste with a plaque indicating dye such
      as PlaqueHD® to disclose plaque while brushing resulted in more than four times as much
      plaque elimination between visits (51.3% reduction, p = 0.015) than participants using only
      the placebo toothpaste (8.3% reduction, p=0.189). 1 However, one of the limitations of the
      product used in that study is the high cost of the toothpaste and the difficulty in obtaining
      the toothpaste in South East Asia.Hence, the present study aims to assess the efficacy of a
      plaque disclosing toothpaste that is easily available and affordable which was developed with
      the Health Promotion Board of Singapore, named Shoplaq® in reducing dental plaque.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: interventional preventive trial
primary purpose: Prevention
masking: Double (Care Provider, Outcomes Assessor)
masking description: Toothpaste tubes will be masked so the care provider would not know which tube he/she allocating to the participants as well the outcome assessor would be masked from both groups ( test and control) so data is assessed unbiased.
measure: Plaque removal efficacy of a disclosing toothpaste
time frame: from Baseline to 1 year
description: Silness and Loe plaque index
measure: Assessment of prevalence and severity of gingivitis in individuals who use the disclosing toothpaste
time frame: from Baseline to 1 year
description: Loe and Silness gingival index
measure: digital image analysis
time frame: from Baseline to 1 year
description: MATLAB software for digital image analysis
measure: adverse effects
time frame: baseline to 1 year
description: To record any side effects or adverse effects of the toothpaste seen by the patient or
clinician. soft tissue changes, taste alteration
measure: patient perceived outcomes
time frame: baseline to 1 year
description: self-administered questionnaire.
arm group label: Control tooth paste
arm group type: Active Comparator
description: controlled fluoridated toothpaste will be provided for brushing to both the groups initially
arm group label: Shoplaque tooth paste
arm group type: Experimental
description: Fluoridated toothpaste with organic plaque disclosing dye will be given to the test group second visit
intervention type: Other
intervention name: Shoplaq toothpaste
description: ACTIVE INGREDIENT Sodium Monofluorophosphate 1000 PPM INGREDIENTS Precipitated Calcium Carbonate, Sorbitol, Glycerin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Sodium Benzoate, DM Water, Colour CI-45410, Holy Basil Oil, Neem Oil, Citrus Oil, Thymol Oi, Clove Oil, Piper Betel Leaf Oil, Tea Tree Oil, Eucalyptus Oil, Peppermint Oil, Spearmint Oil.
Dye containing tooth paste for disclosing plaque and efficient brushing for better oral health.
arm group label: Shoplaque tooth paste
intervention type: Other
intervention name: Colgate toothpaste
description: fluoridated
arm group label: Control tooth paste
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Malaysia
responsible party type: Principal Investigator
investigator affiliation: Segi University
investigator full name: Avita Rath
investigator title: Dr
mesh term: Gingivitis
mesh term: Listerine
mesh term: Sodium Fluoride
sharing ipd: Yes
ipd description: article with study description and result
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: July 2018
ipd access criteria: through journal publication