NCT02676453

Brief Summary

Objective: The aim of this study was to evaluate the effects of dental hygienist support on oral health and attitudes to oral healthcare in nursing homes for older people. Background: Studies in long-term care facilities have indicated that oral health is often unsatisfactory. It is important that nursing staff are able to assist dependent care recipients. Dental hygienist support has been suggested as valuable help. Material and methods: Two nursing homes were randomly selected for intervention and control. Interventions included weekly support from dental hygienists on oral hygiene procedures, prescriptions for individual oral hygiene procedures, and oral care organisational issues. The residents' oral health, measured by dental plaque levels, gingival bleeding and the Revised Oral Assessment Guide (ROAG), was evaluated before and after three months. Attitudes among the staff to oral healthcare were collected through a questionnaire.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 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

September 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

7 months

First QC Date

February 1, 2016

Last Update Submit

February 5, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in dental plaque levels after three months

    Four surfaces (proximal, buccal and lingual surfaces) on each tooth is measured and regarding dental plaque in four levels.

    3 months

  • Changes in gingival bleeding levels after three months

    Four surfaces (proximal, buccal and lingual surfaces) on each tooth is measured and regarding gingival bleeding in four levels.

    3 months

Secondary Outcomes (1)

  • Changes in Revised Oral Assessment Guide, ROAG, after 3 months

    3 months

Other Outcomes (2)

  • Intervention staff evaluation of oral health care at baseline assessed with a questionnaire

    Only once at baseline

  • Intervention staff evaluation of oral health care after 3 months assessed with a questionnaire

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Dental hygienist support

Other: Intervention

control

NO INTERVENTION

Care as usal

Interventions

Dental hygienist support

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents at a nursing home
  • Natural teeth

You may not qualify if:

  • Edentulous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Inger Wårdh, DdS, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 8, 2016

Study Start

September 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share