Domiciliary Professional Oral Care for Dependent Elderly

NCT02669979 | Completed

• 1 other identifier: KarolinskaACT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Gingivitis

Keywords

elderly; oral care

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in bleeding on probing (BoP) each third month

  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.

  12 months

Secondary Outcomes (3)

• Changes from baseline in caries each third month

  12 months

• Changes from baseline in Oral hygiene, each third month

  12 months

• Changes from baseline in oral micro flora, each six month

  12 months

Other Outcomes (4)

• Changes from baseline in episodes with respiratory tract infections each six month

  12 months

• Changes from baseline in Oral Health Related Quality of Life, each six month

  12 month

• Changes from baseline in Knowledge within the nursing staff, each six months

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Care as usual. Common oral hygiene help administered by nursing staff.

Interventions

Intervention OTHER

Professional oral care

Intervention

Eligibility Criteria

• Age: 80 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• The Swedish Research Council: collaborator

Study Sites (1)

Karolinsk institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Dental Caries; Gingivitis

Interventions

Methods

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Inger Wårdh, Assoc prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Associate professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)