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Domiciliary Professional Oral Care for Dependent Elderly

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ClinicalTrials.gov Identifier: NCT02669979
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Inger Wårdh, Karolinska Institutet

Brief Summary:

Today's increase of dentate elderly, many of them dependent, is a challenge, both according to the personal daily oral hygiene and dentistry. This is not only an oral problem, as research findings point to strong associations between oral and general health, even mortality. These findings are especially noticeable in elderly and frail individuals.

Dental care is usually performed in stationary dental clinics where the patients are transported to receive treatment. Dependent elderly dental patients may present many obstacles to traditional dental care due to cognitive limitations or dementia, mobility or transport problems. An alternative is domiciliary dental care where the dental staff performs the treatment by a home visit, in the patients daily living environment. The ability to handle personal oral hygiene is often decreased in these patients and left to overburdened nursing staff that often also lack sufficient knowledge about oral health care, why prophylactic professional oral care is especially important. This type of care can with rather simple equipments be performed as domiciliary treatment of good quality, while more advanced dental care may present restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking.

The aim with this project is to develop domiciliary professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care both according to content and frequency. The overall aim is to establish relevant recommendations for domiciliary prophylactic professional oral care.


Condition or disease Intervention/treatment Phase
Dental Caries Gingivitis Other: Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Domiciliary Professional Oral Care for Dependent Elderly - Access to Improved Oral and General Health?
Actual Study Start Date : January 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Intervention
Intervention in the research groups is professional oral care with tooth brush, "ordinary" fluoridated tooth paste (1100-1450 ppm NaF), and repeated oral care instruction to participants and staff (contact person) , supra gingival depuration if necessary. The group receive treatment each month.
Other: Intervention
Professional oral care

No Intervention: Control
Care as usual. Common oral hygiene help administered by nursing staff.



Primary Outcome Measures :
  1. Changes from baseline in bleeding on probing (BoP) each third month [ Time Frame: 12 months ]
    Primary effect variable: bleeding on probing (BoP) in the gingival sulcus on buccal surfaces concerning the teeth 13, 12, 11, 21, 23, and 33, 32, 31, 41, 43 or the nearest comparable teeth. The bleeding will be scored at four levels (0-3) due to Modified Sulcus Bleeding Index. The measurements are performed at baseline and each third month up to 12 months in both study groups. Comparison will be made on group level.


Secondary Outcome Measures :
  1. Changes from baseline in caries each third month [ Time Frame: 12 months ]
    Manifest caries is registered with the tooth as analysis unit DT (decayed teeth). Measurements are performed each third month up to 12 months in both study groups.

  2. Changes from baseline in Oral hygiene, each third month [ Time Frame: 12 months ]

    Oral hygiene will be measured by Mucosal and plaque index. MPS, that will be used both for fixed teeth and and partial removable dentures. The measurements are performed at baseline and each third month up to 12 months in both study groups.

    The index is composed by a four level plaque score and a four level mucosal score that are added to a composed score in three levels: acceptable, unacceptable, bad


  3. Changes from baseline in oral micro flora, each six month [ Time Frame: 12 months ]
    Oral micro flora: The oral micro flora is measured through sampling collected from the same teeth as above mentioned according to BoP. The measurements are performed at baseline and each six month up to 12 months in both groups on the sub sample of 50 in each group.


Other Outcome Measures:
  1. Changes from baseline in episodes with respiratory tract infections each six month [ Time Frame: 12 months ]
    Number of episodes with respiratory tract infections, pneumonia and use of antibiotics. Data is collected from a registered nurse. Measurements are performed at baseline and each six month up to 12 months in both groups.

  2. Changes from baseline in Oral Health Related Quality of Life, each six month [ Time Frame: 12 month ]
    Oral Health Related Quality of Life will be measured by the validated index GOHAI, Geriatric Oral Health Assessment Index. Measurements are performed at baseline and each six month up to 12 months in both groups.

  3. Changes from baseline in Knowledge within the nursing staff, each six months [ Time Frame: 12 months ]
    The related nursing staff will be evaluated by a questionnaire that deals with the knowledge about oral health. Measurements are performed at baseline and each six month up to 12 months in both groups.

  4. Changes from baseline in attitudes within the nursing staff, each six months [ Time Frame: 12 months ]
    The related nursing staff will be evaluated by an index that deals with attitudes, the nursing DCBS (Dental Coping Beliefs Scale), to oral health. Measurements are performed at baseline and each six month up to 12 months in both groups.



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Ages Eligible for Study:   80 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 or more natural teeth or fixed teeth inclusively osseointegrated implants
  • non smokers,
  • no or mild cognitive impairments

Exclusion criteria:

  • severe cognitive impairments
  • edentulousness and full dentures
  • malignancies and/or immunosuppressive diseases, coagulation defects.

Anticoagulants will be registered but not as an exclusion criteria.


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): NCT02669979


Locations
Sweden
Karolinsk institutet
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
The Swedish Research Council
Investigators
Principal Investigator: Inger Wårdh, Assoc prof Karolinska Institutet

Responsible Party: Inger Wårdh, PhD Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02669979     History of Changes
Other Study ID Numbers: KarolinskaACT
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be be published in scientific papers but not on individual level, only group level

Keywords provided by Inger Wårdh, Karolinska Institutet:
elderly
oral care

Additional relevant MeSH terms:
Dental Caries
Gingivitis
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases