Oral Hygiene Care and Microflora in Elderly Residents
Effect of Weekly Professional Oral Care, During 12 Months, on the Composition of the Oral Flora and Related Variables in Dependent Elderly Residents
1 other identifier
interventional
68
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 4, 2015
CompletedFirst Posted
Study publicly available on registry
December 11, 2015
CompletedAugust 13, 2018
August 1, 2018
1.8 years
November 4, 2015
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composition of the oral microflora
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.
12 months
Secondary Outcomes (3)
Rate of Labial minor gland salivary secretion
12 months
Presence of supragingival-plaque
12 months
Dental status
12 month
Other Outcomes (1)
Prescription medicines
12 months
Study Arms (2)
Control
NO INTERVENTIONCommon oral hygiene help administered by nursing staff
Intervention
EXPERIMENTALExtended professional oral hygiene care Electric toothbrush (Oral-B Professional Care 7000) 1100 ppm sodium fluoride dentifrice (Zendium Classic, Opus Health Care AB/Zendium)
Interventions
Weekly professional oral hygiene performed by dental hygienists
Weekly professional oral hygiene performed by dental hygienists
Weekly professional oral hygiene performed by dental hygienists
Eligibility Criteria
You may qualify if:
- or more natural teeth
- no removable dentures
- no or mild cognitive impairments
You may not qualify if:
- less than 10 natural teeth
- removable dentures
- severe cognitive impairments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- The Swedish Research Councilcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inger Wårdh, Assoc prof
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Associate professor
Study Record Dates
First Submitted
November 4, 2015
First Posted
December 11, 2015
Study Start
August 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2010
Last Updated
August 13, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 20180810
- Access Criteria
- Public
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.