<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/NCT03298620</url>
  </required_header>
  <id_info>
    <org_study_id>REC-2011/915-5</org_study_id>
    <nct_id>NCT03298620</nct_id>
  </id_info>
  <brief_title>Electric and Manual Toothbrushes in Nursing Homes</brief_title>
  <official_title>Effect of Electric Toothbrush on Oral Hygiene in Nursing Home Residents- a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</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>
      Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized&#xD;
      clinical trial for 2 months and followed up 12 months after baseline&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients in nursing homes often have many natural teeth with exposed root surfaces,&#xD;
      bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns,&#xD;
      fillings and implants. In addition they have a limited physical ability, like reduced&#xD;
      muscular strength, rigidness in the neck and spine. All these factors contribute to make it&#xD;
      difficult, both for themselves and their nursing staff to maintain good oral hygiene.&#xD;
&#xD;
      Electrical toothbrushes have been proved effective in removal of dental plaque. There have&#xD;
      also been reports from nursing homes that approves of electrical toothbrushes as a helpful&#xD;
      aid among the nursing staff.&#xD;
&#xD;
      The present study examine if the overall oral hygiene actually improves with the use of&#xD;
      electric toothbrush.&#xD;
&#xD;
      Material and method: The study is a randomized clinical trial (RCT) that includes patients&#xD;
      from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush&#xD;
      Inclusion criteria.&#xD;
&#xD;
        -  Patients living in nursing home in Oslo&#xD;
&#xD;
        -  Provide written informed consent prior to enrolment (from relatives when patients were&#xD;
           assessed by physician to be without ability to give written consent.&#xD;
&#xD;
      Participants in the experimental group use an electrical toothbrush. Participants in the&#xD;
      control group use a standard manual toothbrush.&#xD;
&#xD;
      Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.&#xD;
&#xD;
      After the RCT trial the participants were free to choose toothbrush, electric or manual. The&#xD;
      study includes a follow-up study 10 months after the end of the RCT trial.&#xD;
&#xD;
      The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.&#xD;
&#xD;
      Supervisors:&#xD;
&#xD;
      Tiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos,&#xD;
      Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty,&#xD;
      University of Oslo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2011</start_date>
  <completion_date type="Actual">December 15, 2016</completion_date>
  <primary_completion_date type="Actual">February 28, 2013</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>Randomized Clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>A dental team (dentist and dental hygienist) assessed the outcome measure at baseline and after the two months RCT trial. A neutral dentist implements the intervention after baseline registration. Toothbrushes used in the intervention period is hidden to the dental team during assessments at the end of the RCT period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dental plaque score by use of the Oral Hygiene Index- simplified (OHI-S)</measure>
    <time_frame>baseline, after 2 months, after 12 months</time_frame>
    <description>OHI-S is measuring amount of dental plaque using 6 indicator teeth. Outcome measure: change in OHI-S</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">233</enrollment>
  <condition>Oral Health</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electric toothbrush</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>New standard manual toothbrush</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electric toothbrush</intervention_name>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Manual toothbrush</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients living in nursing home in Oslo&#xD;
&#xD;
          -  Provide written informed consent prior to enrolment (from relatives when patients were&#xD;
             assessed by physician to be without ability to give written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients too weak to be examined&#xD;
&#xD;
          -  Patients With life expectancy less then one year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tiril Willumsen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Clinical Odontology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <zip>0317</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Samson H, Strand GV, Haugejorden O. Change in oral health status among the institutionalized Norwegian elderly over a period of 16 years. Acta Odontol Scand. 2008;66(6):368-73. doi: 10.1080/00016350802378654.</citation>
    <PMID>18792846</PMID>
  </reference>
  <reference>
    <citation>Meurman JH, Hamalainen P. Oral health and morbidity--implications of oral infections on the elderly. Gerodontology. 2006 Mar;23(1):3-16. doi: 10.1111/j.1741-2358.2006.00102.x.</citation>
    <PMID>16433636</PMID>
  </reference>
  <reference>
    <citation>Hamalainen P, Meurman JH, Kauppinen M, Keskinen M. Oral infections as predictors of mortality. Gerodontology. 2005 Sep;22(3):151-7. doi: 10.1111/j.1741-2358.2005.00064.x.</citation>
    <PMID>16163906</PMID>
  </reference>
  <reference>
    <citation>Zuluaga DJ, Ferreira J, Montoya JA, Willumsen T. Oral health in institutionalised elderly people in Oslo, Norway and its relationship with dependence and cognitive impairment. Gerodontology. 2012 Jun;29(2):e420-6. doi: 10.1111/j.1741-2358.2011.00490.x. Epub 2011 May 12.</citation>
    <PMID>21564272</PMID>
  </reference>
  <reference>
    <citation>Henriksen BM, Ambjornsen E, Axell T. Dental caries among the elderly in Norway. Acta Odontol Scand. 2004 Apr;62(2):75-81. doi: 10.1080/00016350310008580.</citation>
    <PMID>15198386</PMID>
  </reference>
  <reference>
    <citation>Wolden H, Strand GV, Gjellestad A. Caregivers' perceptions of electric versus manual toothbrushes for the institutionalised elderly. Gerodontology. 2006 Jun;23(2):106-10. doi: 10.1111/j.1741-2358.2006.00114.x.</citation>
    <PMID>16677184</PMID>
  </reference>
  <reference>
    <citation>Forrest JL, Miller SA. Manual versus powered toothbrushes: a summary of the Cochrane Oral Health Group's Systematic Review. Part II. J Dent Hyg. 2004 Spring;78(2):349-54.</citation>
    <PMID>15190692</PMID>
  </reference>
  <reference>
    <citation>GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.</citation>
    <PMID>14076341</PMID>
  </reference>
  <reference>
    <citation>Henriksen BM, Ambjornsen E, Axell TE. Evaluation of a mucosal-plaque index (MPS) designed to assess oral care in groups of elderly. Spec Care Dentist. 1999 Jul-Aug;19(4):154-7. doi: 10.1111/j.1754-4505.1999.tb01378.x.</citation>
    <PMID>10765880</PMID>
  </reference>
  <reference>
    <citation>Lindqvist L, Seleskog B, Wardh I, von Bultzingslowen I. Oral care perspectives of professionals in nursing homes for the elderly. Int J Dent Hyg. 2013 Nov;11(4):298-305. doi: 10.1111/idh.12016. Epub 2013 Feb 25.</citation>
    <PMID>23433346</PMID>
  </reference>
  <reference>
    <citation>Robinson PG, Damien Walmsley A, Heanue M, Deacon S, Deery C, Glenny AM, Worthington H, Shaw W. Quality of trials in a systematic review of powered toothbrushes: suggestions for future clinical trials. J Periodontol. 2006 Dec;77(12):1944-53. doi: 10.1902/jop.2006.050349.</citation>
    <PMID>17209777</PMID>
  </reference>
  <reference>
    <citation>Deery C, Heanue M, Deacon S, Robinson PG, Walmsley AD, Worthington H, Shaw W, Glenny AM. The effectiveness of manual versus powered toothbrushes for dental health: a systematic review. J Dent. 2004 Mar;32(3):197-211. doi: 10.1016/j.jdent.2003.11.006.</citation>
    <PMID>15001285</PMID>
  </reference>
  <reference>
    <citation>Robinson PG, Deacon SA, Deery C, Heanue M, Walmsley AD, Worthington HV, Glenny AM, Shaw WC. Manual versus powered toothbrushing for oral health. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD002281. doi: 10.1002/14651858.CD002281.pub2.</citation>
    <PMID>15846633</PMID>
  </reference>
  <reference>
    <citation>Hagman-Gustafsson ML, Holmen A, Stromberg E, Gabre P, Wardh I. Who cares for the oral health of dependent elderly and disabled persons living at home? A qualitative study of case managers' knowledge, attitudes and initiatives. Swed Dent J. 2008;32(2):95-104.</citation>
    <PMID>18700337</PMID>
  </reference>
  <reference>
    <citation>Stromberg E, Hagman-Gustafsson ML, Holmen A, Wardh I, Gabre P. Oral status, oral hygiene habits and caries risk factors in home-dwelling elderly dependent on moderate or substantial supportive care for daily living. Community Dent Oral Epidemiol. 2012 Jun;40(3):221-9. doi: 10.1111/j.1600-0528.2011.00653.x. Epub 2011 Nov 9.</citation>
    <PMID>22070521</PMID>
  </reference>
  <reference>
    <citation>Philip P, Rogers C, Kruger E, Tennant M. Caries experience of institutionalized elderly and its association with dementia and functional status. Int J Dent Hyg. 2012 May;10(2):122-7. doi: 10.1111/j.1601-5037.2011.00525.x. Epub 2011 Aug 5.</citation>
    <PMID>21815998</PMID>
  </reference>
  <reference>
    <citation>Arpin S. Oral hygiene in elderly people in hospitals and nursing homes. Evid Based Dent. 2009;10(2):46. doi: 10.1038/sj.ebd.6400649.</citation>
    <PMID>19561578</PMID>
  </reference>
  <reference>
    <citation>Willumsen T, Fjaera B, Eide H. Oral health-related quality of life in patients receiving home-care nursing: associations with aspects of dental status and xerostomia. Gerodontology. 2010 Dec;27(4):251-7. doi: 10.1111/j.1741-2358.2009.00344.x.</citation>
    <PMID>19780842</PMID>
  </reference>
  <reference>
    <citation>Haumschild MS, Haumschild RJ. The importance of oral health in long-term care. J Am Med Dir Assoc. 2009 Nov;10(9):667-71. doi: 10.1016/j.jamda.2009.01.002. Epub 2009 Jun 28.</citation>
    <PMID>19883892</PMID>
  </reference>
  <reference>
    <citation>Marsh PD. Contemporary perspective on plaque control. Br Dent J. 2012 Jun 22;212(12):601-6. doi: 10.1038/sj.bdj.2012.524.</citation>
    <PMID>22722123</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 29, 2017</last_update_submitted>
  <last_update_submitted_qc>September 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Tiril Willumsen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>nursing home</keyword>
  <keyword>gerodontology</keyword>
  <keyword>oral hygiene</keyword>
  <!-- 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/NCT03298620
org study id: REC-2011/915-5
nct id: NCT03298620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Effect of electric toothbrush on oral hygiene in nursing home residents tested I randomized
      clinical trial for 2 months and followed up 12 months after baseline
Patients in nursing homes often have many natural teeth with exposed root surfaces,
      bifurcations, a complexity of dental restorations like partial prostheses, bridges/crowns,
      fillings and implants. In addition they have a limited physical ability, like reduced
      muscular strength, rigidness in the neck and spine. All these factors contribute to make it
      difficult, both for themselves and their nursing staff to maintain good oral hygiene.

      Electrical toothbrushes have been proved effective in removal of dental plaque. There have
      also been reports from nursing homes that approves of electrical toothbrushes as a helpful
      aid among the nursing staff.

      The present study examine if the overall oral hygiene actually improves with the use of
      electric toothbrush.

      Material and method: The study is a randomized clinical trial (RCT) that includes patients
      from nursing homes in Oslo. The recording dentist is blind to the type of tooth brush
      Inclusion criteria.

        -  Patients living in nursing home in Oslo

        -  Provide written informed consent prior to enrolment (from relatives when patients were
           assessed by physician to be without ability to give written consent.

      Participants in the experimental group use an electrical toothbrush. Participants in the
      control group use a standard manual toothbrush.

      Registration of oral hygiene and plaque score at baseline 0 and after 2 months intervention.

      After the RCT trial the participants were free to choose toothbrush, electric or manual. The
      study includes a follow-up study 10 months after the end of the RCT trial.

      The study is a part of the PhD programme for Katrine Gahre Fjeld Cand. Odont.

      Supervisors:

      Tiril Willumsen Dr Odont, The Dental Faculty, University of Oslo Hilde Eide Dr. Philos,
      Department of Nursing, Buskerud University College Morten Mowe Dr med, The Medical Faculty,
      University of Oslo
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Clinical trial
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
masking description: A dental team (dentist and dental hygienist) assessed the outcome measure at baseline and after the two months RCT trial. A neutral dentist implements the intervention after baseline registration. Toothbrushes used in the intervention period is hidden to the dental team during assessments at the end of the RCT period.
measure: Change in dental plaque score by use of the Oral Hygiene Index- simplified (OHI-S)
time frame: baseline, after 2 months, after 12 months
description: OHI-S is measuring amount of dental plaque using 6 indicator teeth. Outcome measure: change in OHI-S
arm group label: Intervention
arm group type: Experimental
description: Electric toothbrush
arm group label: Control
arm group type: Active Comparator
description: New standard manual toothbrush
intervention type: Other
intervention name: Electric toothbrush
arm group label: Intervention
intervention type: Other
intervention name: Control
description: Manual toothbrush
arm group label: Control
criteria: 
gender: All
minimum age: 70 Years
maximum age: 105 Years
healthy volunteers: No
last name: Tiril Willumsen
role: Principal Investigator
affiliation: Institute of Clinical Odontology
facility: 
country: Norway
citation: Samson H, Strand GV, Haugejorden O. Change in oral health status among the institutionalized Norwegian elderly over a period of 16 years. Acta Odontol Scand. 2008;66(6):368-73. doi: 10.1080/00016350802378654.
PMID: 18792846
citation: Meurman JH, Hamalainen P. Oral health and morbidity--implications of oral infections on the elderly. Gerodontology. 2006 Mar;23(1):3-16. doi: 10.1111/j.1741-2358.2006.00102.x.
PMID: 16433636
citation: Hamalainen P, Meurman JH, Kauppinen M, Keskinen M. Oral infections as predictors of mortality. Gerodontology. 2005 Sep;22(3):151-7. doi: 10.1111/j.1741-2358.2005.00064.x.
PMID: 16163906
citation: Zuluaga DJ, Ferreira J, Montoya JA, Willumsen T. Oral health in institutionalised elderly people in Oslo, Norway and its relationship with dependence and cognitive impairment. Gerodontology. 2012 Jun;29(2):e420-6. doi: 10.1111/j.1741-2358.2011.00490.x. Epub 2011 May 12.
PMID: 21564272
citation: Henriksen BM, Ambjornsen E, Axell T. Dental caries among the elderly in Norway. Acta Odontol Scand. 2004 Apr;62(2):75-81. doi: 10.1080/00016350310008580.
PMID: 15198386
citation: Wolden H, Strand GV, Gjellestad A. Caregivers' perceptions of electric versus manual toothbrushes for the institutionalised elderly. Gerodontology. 2006 Jun;23(2):106-10. doi: 10.1111/j.1741-2358.2006.00114.x.
PMID: 16677184
citation: Forrest JL, Miller SA. Manual versus powered toothbrushes: a summary of the Cochrane Oral Health Group's Systematic Review. Part II. J Dent Hyg. 2004 Spring;78(2):349-54.
PMID: 15190692
citation: GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
PMID: 14076341
citation: Henriksen BM, Ambjornsen E, Axell TE. Evaluation of a mucosal-plaque index (MPS) designed to assess oral care in groups of elderly. Spec Care Dentist. 1999 Jul-Aug;19(4):154-7. doi: 10.1111/j.1754-4505.1999.tb01378.x.
PMID: 10765880
citation: Lindqvist L, Seleskog B, Wardh I, von Bultzingslowen I. Oral care perspectives of professionals in nursing homes for the elderly. Int J Dent Hyg. 2013 Nov;11(4):298-305. doi: 10.1111/idh.12016. Epub 2013 Feb 25.
PMID: 23433346
citation: Robinson PG, Damien Walmsley A, Heanue M, Deacon S, Deery C, Glenny AM, Worthington H, Shaw W. Quality of trials in a systematic review of powered toothbrushes: suggestions for future clinical trials. J Periodontol. 2006 Dec;77(12):1944-53. doi: 10.1902/jop.2006.050349.
PMID: 17209777
citation: Deery C, Heanue M, Deacon S, Robinson PG, Walmsley AD, Worthington H, Shaw W, Glenny AM. The effectiveness of manual versus powered toothbrushes for dental health: a systematic review. J Dent. 2004 Mar;32(3):197-211. doi: 10.1016/j.jdent.2003.11.006.
PMID: 15001285
citation: Robinson PG, Deacon SA, Deery C, Heanue M, Walmsley AD, Worthington HV, Glenny AM, Shaw WC. Manual versus powered toothbrushing for oral health. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD002281. doi: 10.1002/14651858.CD002281.pub2.
PMID: 15846633
citation: Hagman-Gustafsson ML, Holmen A, Stromberg E, Gabre P, Wardh I. Who cares for the oral health of dependent elderly and disabled persons living at home? A qualitative study of case managers' knowledge, attitudes and initiatives. Swed Dent J. 2008;32(2):95-104.
PMID: 18700337
citation: Stromberg E, Hagman-Gustafsson ML, Holmen A, Wardh I, Gabre P. Oral status, oral hygiene habits and caries risk factors in home-dwelling elderly dependent on moderate or substantial supportive care for daily living. Community Dent Oral Epidemiol. 2012 Jun;40(3):221-9. doi: 10.1111/j.1600-0528.2011.00653.x. Epub 2011 Nov 9.
PMID: 22070521
citation: Philip P, Rogers C, Kruger E, Tennant M. Caries experience of institutionalized elderly and its association with dementia and functional status. Int J Dent Hyg. 2012 May;10(2):122-7. doi: 10.1111/j.1601-5037.2011.00525.x. Epub 2011 Aug 5.
PMID: 21815998
citation: Arpin S. Oral hygiene in elderly people in hospitals and nursing homes. Evid Based Dent. 2009;10(2):46. doi: 10.1038/sj.ebd.6400649.
PMID: 19561578
citation: Willumsen T, Fjaera B, Eide H. Oral health-related quality of life in patients receiving home-care nursing: associations with aspects of dental status and xerostomia. Gerodontology. 2010 Dec;27(4):251-7. doi: 10.1111/j.1741-2358.2009.00344.x.
PMID: 19780842
citation: Haumschild MS, Haumschild RJ. The importance of oral health in long-term care. J Am Med Dir Assoc. 2009 Nov;10(9):667-71. doi: 10.1016/j.jamda.2009.01.002. Epub 2009 Jun 28.
PMID: 19883892
citation: Marsh PD. Contemporary perspective on plaque control. Br Dent J. 2012 Jun 22;212(12):601-6. doi: 10.1038/sj.bdj.2012.524.
PMID: 22722123
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Tiril Willumsen
investigator title: Professor