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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
Professional oral care
No Intervention: Control
Care as usual. Common oral hygiene help administered by nursing staff.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Inger Wårdh, Assoc prof||Karolinska Institutet|