<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/NCT02202304</url>
  </required_header>
  <id_info>
    <org_study_id>CHLOVADENT</org_study_id>
    <nct_id>NCT02202304</nct_id>
  </id_info>
  <brief_title>The Effects of Chlorhexidine/Thymol Varnish on Partial Denture Patient</brief_title>
  <official_title>The Effects of Chlorhexidine/Thymol Varnish on the Abutment Teeth in Partial Denture Wearers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rosa Moreno Lopez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ivoclar Vivadent AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aberdeen</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>
      Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger&#xD;
      populations. This study wants to investigate if the use of this product would reduce the risk&#xD;
      of losing abutment teeth on patients that are wearing partial dentures as the literature has&#xD;
      proven that these teeth are more prone to caries and periodontal disease.&#xD;
&#xD;
      The primary objectives of this research project are to:&#xD;
&#xD;
        1. Assess if the topical application of CHX/thymol varnish every three months on partial&#xD;
           denture abutment teeth results in a clinicallu significant decrease in any loss of&#xD;
           attachment compared to no application, and&#xD;
&#xD;
        2. Assess if the topical application of CHX/thymol vanirhs every three months on partial&#xD;
           denture abutment teeth results in a clinically significant decrease in carious lesion&#xD;
           development or progression compared to no application.&#xD;
&#xD;
      The secondary objectives of this research project are to:&#xD;
&#xD;
      1. Assess of the topical application of CHX/thymol varnish every three months on partial&#xD;
      denture abutment teeth compared to no application results in a clinically significant&#xD;
      difference in:&#xD;
&#xD;
        1. Bleeding on probing (BoP).&#xD;
&#xD;
        2. Plaque formation.&#xD;
&#xD;
        3. Periodontal pocket depths.&#xD;
&#xD;
        4. Microbial composition and GCF cytokine profile of the sub gingival environment.&#xD;
&#xD;
        5. The patients self perception of oral health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  2 baseline samples of the Gingival Crevicular Fluid (GCF) and the subgingival samples.&#xD;
           The first baseline sample will be done on the day of the first impressions and the&#xD;
           second one the day of denture fitting.&#xD;
&#xD;
        -  The following information will be recorded on the CRFs: Silness and Löe Plaque index,&#xD;
           BoP, probing depth, clinical attachment level, LoA, Kennedy classification, material of&#xD;
           the partial denture and type of clasp (or no clasp) and ICDAS code.&#xD;
&#xD;
        -  The patient will also fill in the OHIP-14 questionnaire (Oral Health Impact Profile) to&#xD;
           assess their self perception of oral health.&#xD;
&#xD;
        -  A photograph of the abutment teeth and the partial denture will be taken.&#xD;
&#xD;
        -  We will also take a full history of the patient including: name, DOB and medications.&#xD;
&#xD;
        -  The GCF and subgingival sampled will be taken every 6 months on the appointment where&#xD;
           the varnish is applied.&#xD;
&#xD;
        -  All the laboratory samples will be labelles with the same identification number that the&#xD;
           patient has been allocated and a date will also be written on it. All the samples will&#xD;
           be analysed in Plymouth and stored in a - 50°C freezer (the samples taken at the&#xD;
           University of Aberdeen will be stored in the same type of freezer and shipped&#xD;
           periodically to the Penninsula University for tests maintaining the same temperature&#xD;
           conditions). They will be testing the microbial composition and GCF cytokine profile of&#xD;
           the sub gingival environment&#xD;
&#xD;
        -  All measurements will be reassessed at 12 months and 24 months. In addition to the&#xD;
           denture hygiene index: Budtz-Jørgensen (1977) Index (plaque accumulation on the&#xD;
           denture).&#xD;
&#xD;
      The data will be collected by one clinician in each dental school. All clinicians will be&#xD;
      calibrated appropriately.&#xD;
&#xD;
      Calibration: Before any examination starts we will assess the consistency of each examiner&#xD;
      (intra-exmainer) and also the variation between exmainers (inter-exmainer reproducibility).&#xD;
      Each examiner will independently examiner the same group of 20 subjects and compare his or&#xD;
      her findings. When findings contain major discrepancies, subjects should be recalled in order&#xD;
      that differences in diagnoses can be reviewed by the exmainers and resolved by group&#xD;
      discussion. If certain examiners consistently produce significantly different results from&#xD;
      the majority, and attmepts to correct their performance fail, they will be excluded from the&#xD;
      team. It will be made clear to all potential examiners, before these exmainations begin, that&#xD;
      ability to standardize examination results is not a measure of clinical skills (Oral Health&#xD;
      Surveys 4th edition. WHO. Geneva 1997) All the data will be recorded on the case report forms&#xD;
      (CRFs).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Researcher changed jobs. Unable to carry out the project&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 10, 2017</start_date>
  <completion_date type="Anticipated">December 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 10, 2019</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess if the topical application of CHX/thymol varnish every three months on partial denture abutment teeth results in a clinicallu significant decrease in any loss of attachment compared to no application</measure>
    <time_frame>Assesed at the begining, at 12 months and at 24 months</time_frame>
    <description>we will measure the Loss of Attachment (LoA) around each abutment tooth at 6 points</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess if the topical application of CHX/thymol vanirhs every three months on partial denture abutment teeth results in a clinically significant decrease in carious lesion development or progression compared to no application</measure>
    <time_frame>at the beginning, at 12 months and at 24 months</time_frame>
    <description>We will record the presence of dental caries using ICDAS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Periodontal Disease</condition>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine/Thymol varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush by &quot;painting&quot; it over the surfaces of these teeth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo varnish</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush and &quot;painting&quot; it on all the surfaces of these teeth..</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine/Thymol varnish</intervention_name>
    <description>This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.</description>
    <arm_group_label>Chlorhexidine/Thymol varnish</arm_group_label>
    <arm_group_label>Placebo varnish</arm_group_label>
    <other_name>Cervitec Plus (1% chlorhexidine plus 1% thymol)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that are going to have a new denture fitted at the Dental School of the&#xD;
             University of Aberdeen and Penninsula Dental School.&#xD;
&#xD;
          -  Patients aged 18 years or over.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that already have a denture.&#xD;
&#xD;
          -  Patients that are taking antibiotics.&#xD;
&#xD;
          -  Patients allergic to any of the components of the products.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Severe systemic illness.&#xD;
&#xD;
          -  Patient with active periodontal disease (BoP and pockets ≥3mm) on abutment teeth.&#xD;
&#xD;
          -  Presence of caries on abutment teeth.&#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>Rosa Moreno Lopez, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Aberdeen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Aberdeen</name>
      <address>
        <city>Aberdeen</city>
        <state>Aberdeenshire</state>
        <zip>AB252ZR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Baca P, Clavero J, Baca AP, Gonzalez-Rodriguez MP, Bravo M, Valderrama MJ. Effect of chlorhexidine-thymol varnish on root caries in a geriatric population: a randomized double-blind clinical trial. J Dent. 2009 Sep;37(9):679-85. doi: 10.1016/j.jdent.2009.05.001. Epub 2009 May 13.</citation>
    <PMID>19497653</PMID>
  </reference>
  <reference>
    <citation>Tanaka J, Tanaka M, Kawazoe T. Longitudinal research on the oral environment of elderly wearing fixed or removable prostheses. J Prosthodont Res. 2009 Apr;53(2):83-8. doi: 10.1016/j.jpor.2008.10.003. Epub 2009 Jan 10.</citation>
    <PMID>19318078</PMID>
  </reference>
  <reference>
    <citation>Shimura Y, Wadachi J, Nakamura T, Mizutani H, Igarashi Y. Influence of removable partial dentures on the formation of dental plaque on abutment teeth. J Prosthodont Res. 2010 Jan;54(1):29-35. doi: 10.1016/j.jpor.2009.08.003. Epub 2009 Oct 8.</citation>
    <PMID>19818702</PMID>
  </reference>
  <reference>
    <citation>Clavero J, Baca P, Paloma Gonzalez M, Valderrama MJ. Efficacy of chlorhexidine-thymol varnish (Cervitec) against plaque accumulation and gingival inflammation in a geriatric population. Gerodontology. 2006 Mar;23(1):43-7. doi: 10.1111/j.1741-2358.2006.00085.x.</citation>
    <PMID>16433641</PMID>
  </reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>May 12, 2017</last_update_submitted>
  <last_update_submitted_qc>May 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Aberdeen</investigator_affiliation>
    <investigator_full_name>Rosa Moreno Lopez</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Thymol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>within 6 months</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/NCT02202304
org study id: CHLOVADENT
nct id: NCT02202304
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cervitec, a chlorhexidine based varnished has been proven to reduce caries risk in younger
      populations. This study wants to investigate if the use of this product would reduce the risk
      of losing abutment teeth on patients that are wearing partial dentures as the literature has
      proven that these teeth are more prone to caries and periodontal disease.

      The primary objectives of this research project are to:

        1. Assess if the topical application of CHX/thymol varnish every three months on partial
           denture abutment teeth results in a clinicallu significant decrease in any loss of
           attachment compared to no application, and

        2. Assess if the topical application of CHX/thymol vanirhs every three months on partial
           denture abutment teeth results in a clinically significant decrease in carious lesion
           development or progression compared to no application.

      The secondary objectives of this research project are to:

      1. Assess of the topical application of CHX/thymol varnish every three months on partial
      denture abutment teeth compared to no application results in a clinically significant
      difference in:

        1. Bleeding on probing (BoP).

        2. Plaque formation.

        3. Periodontal pocket depths.

        4. Microbial composition and GCF cytokine profile of the sub gingival environment.

        5. The patients self perception of oral health.
-  2 baseline samples of the Gingival Crevicular Fluid (GCF) and the subgingival samples.
           The first baseline sample will be done on the day of the first impressions and the
           second one the day of denture fitting.

        -  The following information will be recorded on the CRFs: Silness and Löe Plaque index,
           BoP, probing depth, clinical attachment level, LoA, Kennedy classification, material of
           the partial denture and type of clasp (or no clasp) and ICDAS code.

        -  The patient will also fill in the OHIP-14 questionnaire (Oral Health Impact Profile) to
           assess their self perception of oral health.

        -  A photograph of the abutment teeth and the partial denture will be taken.

        -  We will also take a full history of the patient including: name, DOB and medications.

        -  The GCF and subgingival sampled will be taken every 6 months on the appointment where
           the varnish is applied.

        -  All the laboratory samples will be labelles with the same identification number that the
           patient has been allocated and a date will also be written on it. All the samples will
           be analysed in Plymouth and stored in a - 50°C freezer (the samples taken at the
           University of Aberdeen will be stored in the same type of freezer and shipped
           periodically to the Penninsula University for tests maintaining the same temperature
           conditions). They will be testing the microbial composition and GCF cytokine profile of
           the sub gingival environment

        -  All measurements will be reassessed at 12 months and 24 months. In addition to the
           denture hygiene index: Budtz-Jørgensen (1977) Index (plaque accumulation on the
           denture).

      The data will be collected by one clinician in each dental school. All clinicians will be
      calibrated appropriately.

      Calibration: Before any examination starts we will assess the consistency of each examiner
      (intra-exmainer) and also the variation between exmainers (inter-exmainer reproducibility).
      Each examiner will independently examiner the same group of 20 subjects and compare his or
      her findings. When findings contain major discrepancies, subjects should be recalled in order
      that differences in diagnoses can be reviewed by the exmainers and resolved by group
      discussion. If certain examiners consistently produce significantly different results from
      the majority, and attmepts to correct their performance fail, they will be excluded from the
      team. It will be made clear to all potential examiners, before these exmainations begin, that
      ability to standardize examination results is not a measure of clinical skills (Oral Health
      Surveys 4th edition. WHO. Geneva 1997) All the data will be recorded on the case report forms
      (CRFs).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Assess if the topical application of CHX/thymol varnish every three months on partial denture abutment teeth results in a clinicallu significant decrease in any loss of attachment compared to no application
time frame: Assesed at the begining, at 12 months and at 24 months
description: we will measure the Loss of Attachment (LoA) around each abutment tooth at 6 points
measure: Assess if the topical application of CHX/thymol vanirhs every three months on partial denture abutment teeth results in a clinically significant decrease in carious lesion development or progression compared to no application
time frame: at the beginning, at 12 months and at 24 months
description: We will record the presence of dental caries using ICDAS
arm group label: Chlorhexidine/Thymol varnish
arm group type: Experimental
description: Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush by "painting" it over the surfaces of these teeth.
arm group label: Placebo varnish
arm group type: Placebo Comparator
description: Participants to the study will receive an application of either the placebo or the product being studied every 3 months. This will be applied on all abutment teeth using a microbrush and "painting" it on all the surfaces of these teeth..
intervention type: Drug
intervention name: Chlorhexidine/Thymol varnish
description: This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
arm group label: Chlorhexidine/Thymol varnish
arm group label: Placebo varnish
other name: Cervitec Plus (1% chlorhexidine plus 1% thymol)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rosa Moreno Lopez, BDS
role: Principal Investigator
affiliation: University of Aberdeen
facility: 
country: United Kingdom
citation: Baca P, Clavero J, Baca AP, Gonzalez-Rodriguez MP, Bravo M, Valderrama MJ. Effect of chlorhexidine-thymol varnish on root caries in a geriatric population: a randomized double-blind clinical trial. J Dent. 2009 Sep;37(9):679-85. doi: 10.1016/j.jdent.2009.05.001. Epub 2009 May 13.
PMID: 19497653
citation: Tanaka J, Tanaka M, Kawazoe T. Longitudinal research on the oral environment of elderly wearing fixed or removable prostheses. J Prosthodont Res. 2009 Apr;53(2):83-8. doi: 10.1016/j.jpor.2008.10.003. Epub 2009 Jan 10.
PMID: 19318078
citation: Shimura Y, Wadachi J, Nakamura T, Mizutani H, Igarashi Y. Influence of removable partial dentures on the formation of dental plaque on abutment teeth. J Prosthodont Res. 2010 Jan;54(1):29-35. doi: 10.1016/j.jpor.2009.08.003. Epub 2009 Oct 8.
PMID: 19818702
citation: Clavero J, Baca P, Paloma Gonzalez M, Valderrama MJ. Efficacy of chlorhexidine-thymol varnish (Cervitec) against plaque accumulation and gingival inflammation in a geriatric population. Gerodontology. 2006 Mar;23(1):43-7. doi: 10.1111/j.1741-2358.2006.00085.x.
PMID: 16433641
responsible party type: Sponsor-Investigator
investigator affiliation: University of Aberdeen
investigator full name: Rosa Moreno Lopez
investigator title: Dr
mesh term: Periodontal Diseases
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Thymol
sharing ipd: Yes
ipd description: within 6 months