<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/NCT04432415</url>
  </required_header>
  <id_info>
    <org_study_id>UNAMexico CIE/0810/03/2017</org_study_id>
    <nct_id>NCT04432415</nct_id>
  </id_info>
  <brief_title>Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults</brief_title>
  <official_title>Comparison of the Efficacy of Silver Diamine Fluoride Solution and Sodium Fluoride Varnish for the Prevention and Arrest of Root Caries in a Group of Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Nacional Autonoma de Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sistema para el Desarrollo Integral de la Familia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad Nacional Autonoma de Mexico</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>
      Dental caries (coronal and root) is highly prevalent in older adults. It is important to&#xD;
      identify and implement the most effective methods that prevent the formation of root caries&#xD;
      lesions and inhibit existing lesions at the community level.&#xD;
&#xD;
      A clinical trial will be conducted in three groups of adults 60 years old and older,&#xD;
      comparing the application of silver diamine fluoride solution and sodium fluoride varnish in&#xD;
      dental root surfaces with caries and sound root surfaces. The objectives are to determine&#xD;
      over a 30-month period which of the two agents is most effective in reducing the incidence of&#xD;
      root caries, and which is most effective in arresting active root caries lesions.&#xD;
&#xD;
      Hypothesis: the incidence of root caries will be lower in the group of subjects treated with&#xD;
      silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root&#xD;
      lesions will be higher when using silver diamine fluoride compared to sodium fluoride&#xD;
      varnish.&#xD;
&#xD;
      Signed informed consent will be requested from persons 60 years and over, residents of four&#xD;
      long-term care centers and attendees of a day care center in four central states of Mexico:&#xD;
      Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by&#xD;
      the National System for Integral Family Development (IFD), a public welfare institution that&#xD;
      works at the federal and state levels.&#xD;
&#xD;
      Three groups will be formed (60 participants in each), two groups will be administered each&#xD;
      of the agents, the third group will be the control group. All groups will receive dental&#xD;
      health education (oral hygiene, instructions for care and hygiene of removable dental&#xD;
      prosthesis, information on prevention of coronal and root caries and periodontal diseases).&#xD;
      The preventive agents will be administered according to the manufacturer's instructions.&#xD;
      Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The&#xD;
      incidence of root caries among the groups will be compared with the percentage of active root&#xD;
      lesions that were arrested and that remained inactive.&#xD;
&#xD;
      If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in&#xD;
      caries preventive programs for older persons, reducing the risk of tooth loss and improving&#xD;
      quality of life. It will also serve as a guide for dental surgeon in-office decision-making&#xD;
      regarding the method to use to prevent and limit root caries lesions in older adults at risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is an increase in the incidence and prevalence of chronic diseases, including oral&#xD;
      problems in older persons. Coronal and root caries, and periodontitis represent the main&#xD;
      causes of tooth loss, and in older adults they have a great impact on quality of life,&#xD;
      nutritional status, social life, and the increased risk of systemic problems related to&#xD;
      dental infectious processes. At present, older adults have more remaining teeth and dental&#xD;
      caries is highly prevalent. It is important to investigate and implement methods that prevent&#xD;
      the formation of new carious lesions and that arrest existing lesions. The utilization of&#xD;
      silver diamine fluoride as a method to prevent coronal caries has been recognized and has&#xD;
      proven to be highly effective in treating dentin hypersensitivity and arresting active&#xD;
      lesions, also it is easy to apply. Therefore, it is important and necessary to implement&#xD;
      methods that avoid the formation of lesions and that inhibit the root caries lesions already&#xD;
      present.&#xD;
&#xD;
      If greater effectiveness of silver diamine fluoride in preventing and arresting active root&#xD;
      caries is confirmed, its use in conjunction with oral health education can be proposed as a&#xD;
      preventive method to be included in oral health programs in institutionalized persons in whom&#xD;
      dental care and attention are less frequent. Its ease of application, the longer time between&#xD;
      applications and its cost can facilitate better oral care. On the other hand, the results can&#xD;
      guide professionals in clinical practice in making decisions regarding the most appropriate&#xD;
      method to prevent and arrest root caries lesions in their patients.&#xD;
&#xD;
      Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be&#xD;
      lower on root surfaces that have been treated with silver diamine fluoride solution (38%&#xD;
      concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5%&#xD;
      concentration [22,600 ppm]) and to those in the control group (artificial saliva).&#xD;
&#xD;
      The number of active root caries lesions arrested at baseline will be higher in people who&#xD;
      have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm])&#xD;
      compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and&#xD;
      with the control group (artificial saliva).&#xD;
&#xD;
      General objective:&#xD;
&#xD;
      To identify whether the annual application of silver diamine fluoride solution combined with&#xD;
      an individualized oral health education program is more effective than biannual application&#xD;
      of sodium fluoride varnish combined with an individualized oral health education program and&#xD;
      a group control (artificial saliva and oral health individualized educational program) in the&#xD;
      reduction of the incidence of root caries and in the arrest of active root caries lesions&#xD;
      over a period of 30 months in a population of adults over 60 years of age in residents of 4&#xD;
      gerontological centers and a DIF day care center, in 2017-2020.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        -  To compare the incidence of root caries after 30 months in three groups receiving the&#xD;
           annual application of silver diamine fluoride solution (44800 ppm), the biannual&#xD;
           application of sodium fluoride varnish (22600 ppm) and the biannual application of&#xD;
           artificial saliva respectively, controlling for age, gender, frequency of toothbrushing,&#xD;
           use of dental floss, use of removable prostheses.&#xD;
&#xD;
        -  To compare the number of active root carious lesions arrested at baseline after annual&#xD;
           application of silver diamine fluoride solution (44,800 ppm) and biannual application of&#xD;
           sodium fluoride varnish (22,600 ppm) and biannual application of artificial saliva, all&#xD;
           combined with an individualized oral health education program, controlling by age,&#xD;
           gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.&#xD;
&#xD;
        -  To design and implement an individualized oral health education program on prevention&#xD;
           and treatment of root and coronal caries, promotion and reinforcement of toothbrushing,&#xD;
           and the proper care and cleaning of removable prostheses.&#xD;
&#xD;
      METHODS Area: clinical research Study type: Intervention Study design: randomized controlled&#xD;
      clinical trial. Study characteristics: prospective, longitudinal, comparative. Participant&#xD;
      allocation: randomized Study classification: efficacy study Intervention model: parallel&#xD;
      groups Masking: blind (participant) Main purpose: Prevention Study population Residents of&#xD;
      four gerontological centers &quot;Arturo Mundet&quot; (Mexico City), &quot;Vicente García Torres&quot; (Mexico&#xD;
      City), &quot;Los Tamayo&quot; (Oaxaca, Oaxaca) and &quot;Olga Tamayo&quot; (Cuernavaca, Morelos ) and a day care&#xD;
      center in Santa Ana Tlapaltitlán (Toluca, State of Mexico). All centers are administered by&#xD;
      the National System for Integral Family Development, a public welfare institution that works&#xD;
      at the federal and state levels.&#xD;
&#xD;
      Sample size Three groups of size 60 are required, in a no probabilistic convenience sampling.&#xD;
&#xD;
      The administration will be carried out in the same way in the three groups using a mini&#xD;
      applicator brush.&#xD;
&#xD;
      Control group: biannual application of artificial saliva on exposed root surfaces. Sodium&#xD;
      Fluoride varnish: biannual application of sodium fluoride varnish (22,600 ppm) on exposed&#xD;
      healthy root surfaces and application at baseline and biannually on active root lesions.&#xD;
      Silver Diamine Fluoride: annual application of silver diamine fluoride solution (44800ppm) on&#xD;
      exposed healthy root surfaces and alternate annual application of artificial saliva, as well&#xD;
      as initial and annual application on active root lesions.&#xD;
&#xD;
      Before data collection persons will be invited to participate, the purpose of the study will&#xD;
      be explained, and if they accept will be examined to identify whether they meet the selection&#xD;
      criteria.&#xD;
&#xD;
      Once the participants have been selected and signed the informed consent, they will be&#xD;
      randomly assigned to one of the three groups. The baseline questionnaire on knowledge,&#xD;
      attitudes and practices, the clinical evaluation and the initial application of the&#xD;
      preventive agents or placebo, and the first personalized oral health education session will&#xD;
      be carried out.The clinical examination will be carried out in each center using a portable&#xD;
      dental unit and artificial light.&#xD;
&#xD;
      The evaluations will be repeated at 6, 12, 18, 24 and 30 months. The examiner will be&#xD;
      standardized for the evaluation of root caries using the International Caries Detection and&#xD;
      Assessment System (ICDAS) for root caries, and in the assessment of dental plaque and dental&#xD;
      calculus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Coronavirus Pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Participants will be assigned randomly into treatment and control group using a randomization protocol.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participants will not know which type of fluoride they are getting. Outcome assesor will not know the type of fluoride or placebo assigned to each group</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of root caries lesions</measure>
    <time_frame>30 months</time_frame>
    <description>Number of new caries lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arrested root caries lesions</measure>
    <time_frame>30 months</time_frame>
    <description>number of active root caries lesions arrested (non active)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Root Caries</condition>
  <arm_group>
    <arm_group_label>Group Silver Diamine Fluoride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Sodium Fluoride Varnish</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive semestral apllications of artificial saliva and a personalized dental health education program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Silver Diamine Fluoride</intervention_name>
    <description>Annual application od Silver Diamine Fluoride</description>
    <arm_group_label>Group Silver Diamine Fluoride</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Soduim Fluoride Varnish</intervention_name>
    <description>biannual apllication of Sodium Fluoride Varnish</description>
    <arm_group_label>Group Sodium Fluoride Varnish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>biannual application of artificial saliva</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults 60 years of age and older&#xD;
&#xD;
          -  At least 5 teeth with gingival recession and exposed root surfaces not indicated for&#xD;
             extraction&#xD;
&#xD;
          -  No problems performing activities of daily living&#xD;
&#xD;
          -  Agree to participate and sign the informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Health problems that prevent oral hygiene&#xD;
&#xD;
          -  Cognitive problems that prevent understanding oral hygiene instructions&#xD;
&#xD;
          -  Salivary gland diseases (hyposalivation)&#xD;
&#xD;
          -  Having received radiation therapy to the head and neck&#xD;
&#xD;
          -  Deafness&#xD;
&#xD;
          -  Active infections of the oral mucosa&#xD;
&#xD;
          -  Allergy to silver&#xD;
&#xD;
          -  Stomatitis&#xD;
&#xD;
          -  Allergy to colophony (component of varnishes)&#xD;
&#xD;
        Elimination criteria:&#xD;
&#xD;
        -Adults who do not return to subsequent applications of silver diamine fluoride, sodium&#xD;
        fluoride varnish, or artificial saliva.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aida Borges-Yañez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Nacional Autonoma de Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Gerontológico Arturo Mundet</name>
      <address>
        <city>Mexico City</city>
        <zip>01040</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Deutsch A. An alternate technique of care using silver fluoride followed by stannous fluoride in the management of root caries in aged care. Spec Care Dentist. 2016 Mar-Apr;36(2):85-92. doi: 10.1111/scd.12153. Epub 2015 Dec 21.</citation>
    <PMID>26687774</PMID>
  </reference>
  <reference>
    <citation>Tan HP, Lo EC, Dyson JE, Luo Y, Corbet EF. A randomized trial on root caries prevention in elders. J Dent Res. 2010 Oct;89(10):1086-90. doi: 10.1177/0022034510375825. Epub 2010 Jul 29.</citation>
    <PMID>20671206</PMID>
  </reference>
  <reference>
    <citation>Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.</citation>
    <PMID>23392087</PMID>
  </reference>
  <reference>
    <citation>Sequeira-Byron P, Lussi A. Prevention of root caries. Evid Based Dent. 2011;12(3):70-1. doi: 10.1038/sj.ebd.6400805.</citation>
    <PMID>21979764</PMID>
  </reference>
  <reference>
    <citation>Richards D. Fluoride has a beneficial effect on root caries. Evid Based Dent. 2009;10(1):12. doi: 10.1038/sj.ebd.6400627.</citation>
    <PMID>19322220</PMID>
  </reference>
  <reference>
    <citation>Twetman S, Keller MK. Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials. Caries Res. 2016;50 Suppl 1:38-44. doi: 10.1159/000439180. Epub 2016 Apr 22.</citation>
    <PMID>27101002</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Nacional Autonoma de Mexico</investigator_affiliation>
    <investigator_full_name>Aida Borges</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>root caries</keyword>
  <keyword>Fluorides</keyword>
  <keyword>aged</keyword>
  <keyword>incidence</keyword>
  <keyword>Mexico</keyword>
  <keyword>Long-Term Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Root Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</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/NCT04432415
org study id: UNAMexico CIE/0810/03/2017
nct id: NCT04432415
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dental caries (coronal and root) is highly prevalent in older adults. It is important to
      identify and implement the most effective methods that prevent the formation of root caries
      lesions and inhibit existing lesions at the community level.

      A clinical trial will be conducted in three groups of adults 60 years old and older,
      comparing the application of silver diamine fluoride solution and sodium fluoride varnish in
      dental root surfaces with caries and sound root surfaces. The objectives are to determine
      over a 30-month period which of the two agents is most effective in reducing the incidence of
      root caries, and which is most effective in arresting active root caries lesions.

      Hypothesis: the incidence of root caries will be lower in the group of subjects treated with
      silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root
      lesions will be higher when using silver diamine fluoride compared to sodium fluoride
      varnish.

      Signed informed consent will be requested from persons 60 years and over, residents of four
      long-term care centers and attendees of a day care center in four central states of Mexico:
      Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by
      the National System for Integral Family Development (IFD), a public welfare institution that
      works at the federal and state levels.

      Three groups will be formed (60 participants in each), two groups will be administered each
      of the agents, the third group will be the control group. All groups will receive dental
      health education (oral hygiene, instructions for care and hygiene of removable dental
      prosthesis, information on prevention of coronal and root caries and periodontal diseases).
      The preventive agents will be administered according to the manufacturer's instructions.
      Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The
      incidence of root caries among the groups will be compared with the percentage of active root
      lesions that were arrested and that remained inactive.

      If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in
      caries preventive programs for older persons, reducing the risk of tooth loss and improving
      quality of life. It will also serve as a guide for dental surgeon in-office decision-making
      regarding the method to use to prevent and limit root caries lesions in older adults at risk.
There is an increase in the incidence and prevalence of chronic diseases, including oral
      problems in older persons. Coronal and root caries, and periodontitis represent the main
      causes of tooth loss, and in older adults they have a great impact on quality of life,
      nutritional status, social life, and the increased risk of systemic problems related to
      dental infectious processes. At present, older adults have more remaining teeth and dental
      caries is highly prevalent. It is important to investigate and implement methods that prevent
      the formation of new carious lesions and that arrest existing lesions. The utilization of
      silver diamine fluoride as a method to prevent coronal caries has been recognized and has
      proven to be highly effective in treating dentin hypersensitivity and arresting active
      lesions, also it is easy to apply. Therefore, it is important and necessary to implement
      methods that avoid the formation of lesions and that inhibit the root caries lesions already
      present.

      If greater effectiveness of silver diamine fluoride in preventing and arresting active root
      caries is confirmed, its use in conjunction with oral health education can be proposed as a
      preventive method to be included in oral health programs in institutionalized persons in whom
      dental care and attention are less frequent. Its ease of application, the longer time between
      applications and its cost can facilitate better oral care. On the other hand, the results can
      guide professionals in clinical practice in making decisions regarding the most appropriate
      method to prevent and arrest root caries lesions in their patients.

      Hypothesis The incidence of root caries (new root caries lesions) after 30 months will be
      lower on root surfaces that have been treated with silver diamine fluoride solution (38%
      concentration [44800 ppm]) compared to those treated with sodium fluoride varnish (5%
      concentration [22,600 ppm]) and to those in the control group (artificial saliva).

      The number of active root caries lesions arrested at baseline will be higher in people who
      have been treated with silver diamine fluoride solution (38% concentration [44,800 ppm])
      compared to those treated with sodium fluoride varnish (5% concentration [22600 ppm]) and
      with the control group (artificial saliva).

      General objective:

      To identify whether the annual application of silver diamine fluoride solution combined with
      an individualized oral health education program is more effective than biannual application
      of sodium fluoride varnish combined with an individualized oral health education program and
      a group control (artificial saliva and oral health individualized educational program) in the
      reduction of the incidence of root caries and in the arrest of active root caries lesions
      over a period of 30 months in a population of adults over 60 years of age in residents of 4
      gerontological centers and a DIF day care center, in 2017-2020.

      Specific objectives:

        -  To compare the incidence of root caries after 30 months in three groups receiving the
           annual application of silver diamine fluoride solution (44800 ppm), the biannual
           application of sodium fluoride varnish (22600 ppm) and the biannual application of
           artificial saliva respectively, controlling for age, gender, frequency of toothbrushing,
           use of dental floss, use of removable prostheses.

        -  To compare the number of active root carious lesions arrested at baseline after annual
           application of silver diamine fluoride solution (44,800 ppm) and biannual application of
           sodium fluoride varnish (22,600 ppm) and biannual application of artificial saliva, all
           combined with an individualized oral health education program, controlling by age,
           gender, frequency of toothbrushing, use of dental floss, use of removable prostheses.

        -  To design and implement an individualized oral health education program on prevention
           and treatment of root and coronal caries, promotion and reinforcement of toothbrushing,
           and the proper care and cleaning of removable prostheses.

      METHODS Area: clinical research Study type: Intervention Study design: randomized controlled
      clinical trial. Study characteristics: prospective, longitudinal, comparative. Participant
      allocation: randomized Study classification: efficacy study Intervention model: parallel
      groups Masking: blind (participant) Main purpose: Prevention Study population Residents of
      four gerontological centers "Arturo Mundet" (Mexico City), "Vicente García Torres" (Mexico
      City), "Los Tamayo" (Oaxaca, Oaxaca) and "Olga Tamayo" (Cuernavaca, Morelos ) and a day care
      center in Santa Ana Tlapaltitlán (Toluca, State of Mexico). All centers are administered by
      the National System for Integral Family Development, a public welfare institution that works
      at the federal and state levels.

      Sample size Three groups of size 60 are required, in a no probabilistic convenience sampling.

      The administration will be carried out in the same way in the three groups using a mini
      applicator brush.

      Control group: biannual application of artificial saliva on exposed root surfaces. Sodium
      Fluoride varnish: biannual application of sodium fluoride varnish (22,600 ppm) on exposed
      healthy root surfaces and application at baseline and biannually on active root lesions.
      Silver Diamine Fluoride: annual application of silver diamine fluoride solution (44800ppm) on
      exposed healthy root surfaces and alternate annual application of artificial saliva, as well
      as initial and annual application on active root lesions.

      Before data collection persons will be invited to participate, the purpose of the study will
      be explained, and if they accept will be examined to identify whether they meet the selection
      criteria.

      Once the participants have been selected and signed the informed consent, they will be
      randomly assigned to one of the three groups. The baseline questionnaire on knowledge,
      attitudes and practices, the clinical evaluation and the initial application of the
      preventive agents or placebo, and the first personalized oral health education session will
      be carried out.The clinical examination will be carried out in each center using a portable
      dental unit and artificial light.

      The evaluations will be repeated at 6, 12, 18, 24 and 30 months. The examiner will be
      standardized for the evaluation of root caries using the International Caries Detection and
      Assessment System (ICDAS) for root caries, and in the assessment of dental plaque and dental
      calculus.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be assigned randomly into treatment and control group using a randomization protocol.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: Participants will not know which type of fluoride they are getting. Outcome assesor will not know the type of fluoride or placebo assigned to each group
measure: Incidence of root caries lesions
time frame: 30 months
description: Number of new caries lesions
measure: Arrested root caries lesions
time frame: 30 months
description: number of active root caries lesions arrested (non active)
arm group label: Group Silver Diamine Fluoride
arm group type: Experimental
description: Participants receive Annual applications of 38% SDF solution and semestral applications of artificial saliva and a personalized dental health education program.
arm group label: Group Sodium Fluoride Varnish
arm group type: Experimental
description: Participants receive semestral applications of Sodium Varnish Fluoride and a personalized dental health education program.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants receive semestral apllications of artificial saliva and a personalized dental health education program.
intervention type: Device
intervention name: Silver Diamine Fluoride
description: Annual application od Silver Diamine Fluoride
arm group label: Group Silver Diamine Fluoride
intervention type: Device
intervention name: Soduim Fluoride Varnish
description: biannual apllication of Sodium Fluoride Varnish
arm group label: Group Sodium Fluoride Varnish
intervention type: Device
intervention name: Placebo
description: biannual application of artificial saliva
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aida Borges-Yañez, PhD
role: Principal Investigator
affiliation: Universidad Nacional Autonoma de Mexico
facility: 
country: Mexico
citation: Deutsch A. An alternate technique of care using silver fluoride followed by stannous fluoride in the management of root caries in aged care. Spec Care Dentist. 2016 Mar-Apr;36(2):85-92. doi: 10.1111/scd.12153. Epub 2015 Dec 21.
PMID: 26687774
citation: Tan HP, Lo EC, Dyson JE, Luo Y, Corbet EF. A randomized trial on root caries prevention in elders. J Dent Res. 2010 Oct;89(10):1086-90. doi: 10.1177/0022034510375825. Epub 2010 Jul 29.
PMID: 20671206
citation: Zhang W, McGrath C, Lo EC, Li JY. Silver diamine fluoride and education to prevent and arrest root caries among community-dwelling elders. Caries Res. 2013;47(4):284-90. doi: 10.1159/000346620. Epub 2013 Feb 5.
PMID: 23392087
citation: Sequeira-Byron P, Lussi A. Prevention of root caries. Evid Based Dent. 2011;12(3):70-1. doi: 10.1038/sj.ebd.6400805.
PMID: 21979764
citation: Richards D. Fluoride has a beneficial effect on root caries. Evid Based Dent. 2009;10(1):12. doi: 10.1038/sj.ebd.6400627.
PMID: 19322220
citation: Twetman S, Keller MK. Fluoride Rinses, Gels and Foams: An Update of Controlled Clinical Trials. Caries Res. 2016;50 Suppl 1:38-44. doi: 10.1159/000439180. Epub 2016 Apr 22.
PMID: 27101002
responsible party type: Principal Investigator
investigator affiliation: Universidad Nacional Autonoma de Mexico
investigator full name: Aida Borges
investigator title: Principal investigator
mesh term: Root Caries
mesh term: Fluorides
mesh term: Fluorides, Topical
sharing ipd: No