NCT02627469

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Typical duration for not_applicable

Status
completed

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

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

November 4, 2015

Last Update Submit

August 10, 2018

Conditions

Keywords

Microbiotaagedoral health

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 INTERVENTION

Common oral hygiene help administered by nursing staff

Intervention

EXPERIMENTAL

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 careDevice: Electric toothbrush (Oral-B Professional Care 7000)Device: 1100 ppm sodium fluoride dentifrice (Zendium Classic)

Interventions

Weekly professional oral hygiene performed by dental hygienists

Intervention

Weekly professional oral hygiene performed by dental hygienists

Intervention

Weekly professional oral hygiene performed by dental hygienists

Intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Inger Wårdh, Assoc prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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

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

Available IPD Datasets

Clinical Study Report Access