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Oral Hygiene Care and Microflora in Elderly Residents

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ClinicalTrials.gov Identifier: NCT02627469
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Inger Wårdh, Karolinska Institutet

Brief Summary:

Objective: The effect of weekly professional oral care on the composition of the oral flora in dentate, dependent elderly residents was followed during a 12-month period.

Background: Long-term, regular professional oral hygiene care reduces the total number of microorganisms and oral disease-related microorganisms. Less is known about the effect on the quality/composition of the remaining oral flora.

Materials and methods: Thirty-three subjects were included in the study group and 35 in the control group. Dental status, presence of supragingival-plaque, labial minor gland secretion rate, and prescription medicines were recorded. Microbial samples, collected from supragingival plaque and the dorsum of the tongue, were analyzed using cultivation technique.


Condition or disease Intervention/treatment Phase
Pneumonia Aspiration Behavioral: Extended professional oral hygiene care Device: Electric toothbrush (Oral-B Professional Care 7000) Device: 1100 ppm sodium fluoride dentifrice (Zendium Classic) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Weekly Professional Oral Care, During 12 Months, on the Composition of the Oral Flora and Related Variables in Dependent Elderly Residents
Study Start Date : August 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
No Intervention: Control
Common oral hygiene help administered by nursing staff
Experimental: Intervention
Extended professional oral hygiene care Electric toothbrush (Oral-B Professional Care 7000) 1100 ppm sodium fluoride dentifrice (Zendium Classic, Opus Health Care AB/Zendium)
Behavioral: Extended professional oral hygiene care
Weekly professional oral hygiene performed by dental hygienists

Device: Electric toothbrush (Oral-B Professional Care 7000)
Weekly professional oral hygiene performed by dental hygienists

Device: 1100 ppm sodium fluoride dentifrice (Zendium Classic)
Weekly professional oral hygiene performed by dental hygienists




Primary Outcome Measures :
  1. Composition of the oral microflora [ Time Frame: 12 months ]

    Microbial samples were collected from the supragingival plaque and the dorsum of the tongue.

    The total number of microorganisms growing under anaerobic conditions, the total number and proportion of streptococci, lactobacilli, Actinomyces spp, F. nucleatum, P. intermedia/nigrescens, P. gingivalis, A. actinomycetemcomitans, Candida albicans, Staphylococcus aureus, and enteric rods, were calculated.

    The detection limit was 100 colony-forming units for all species except A. actinomycetemcomitans, where the detection limit was 10 colony-forming units. If possible, the number of microorganisms was calculated from their number on a plate giving 30 - 300 colonies. A mean of the results from the duplicate samplings was calculated.



Secondary Outcome Measures :
  1. Rate of Labial minor gland salivary secretion [ Time Frame: 12 months ]
    For measurement of the labial minor gland salivary secretion rate, the area of the lower labial mucosa was gently dried with a cotton pad. A pre-cut piece of a standard filter paper was then placed for 15 s near the midline approximately 3 mm from the outer border of the mucosa. The volume of liquid absorbed by the filter paper was measured using a calibrated Periotron® (8000, ProFlow™ Inc., Amityville, NY, USA). At each examination, four samples were collected from each subject and an individual mean was calculated.

  2. Presence of supragingival-plaque [ Time Frame: 12 months ]
    Plaque was recorded as no visible plaque (score 0), visible but thin plaque (score 1) or visible thick plaque (score 2). A mean of the plaque scores recorded at the four interproximal sites selected for registration was calculated.

  3. Dental status [ Time Frame: 12 month ]
    A clinical examination was carried out, in the light of an adjustable headlight, using a dental mirror and a dental probe. The number of natural teeth and clinically visible caries lesions were recorded.


Other Outcome Measures:
  1. Prescription medicines [ Time Frame: 12 months ]
    Data on prescription medicines was collected from the residents´ medical records.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 10 or more natural teeth
  • no removable dentures
  • no or mild cognitive impairments

Exclusion criteria

  • less than 10 natural teeth
  • removable dentures
  • severe cognitive impairments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627469


Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
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Principal Investigator: Inger Wårdh, Assoc prof Karolinska Institutet

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site

The study is reported in the paper:

Effect of 12-month weekly professional oral hygiene care on the composition of the oral flora in dentate, dependent elderly residents: A prospective study.

Wikström M, Kareem KL, Almståhl A, Palmgren E, Lingström P, Wårdh I.

Gerodontology. 2017 Jun;34(2):240-248



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Responsible Party: Inger Wårdh, PhD Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02627469     History of Changes
Other Study ID Numbers: KarolinskaII
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Published data will not be able to connect with an specific individual but each participant is allowed to by request take part of their own data.
Time Frame: 20180810
Access Criteria: Public

Keywords provided by Inger Wårdh, Karolinska Institutet:
Microbiota
aged
oral health

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Listerine
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents