Domiciliary Professional Oral Care for Dependent Elderly
Condition: Dental Caries; Gingivitis
MeSH terms: Gingivitis; Dental Caries
Study type: Interventional

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.
    

Detailed description: 
      Background:

      An increasing number of research publications point to the association between oral and
      general health. There are reports about associations between oral infections, coronary
      diseases, diabetes and respiratory tract infections but also between a high oral
      opportunistic micro flora and increased mortality in frail elderly individuals. It is
      important to develop oral care methods that effectively prevent the growth of an
      opportunistic micro flora and och oral diseases. Especially important is preventive methods
      in old and dependent individuals as these vulnerable patients groups have limited
      possibilities and access to relevant oral health care.

      Professional oral care have been seen as an effective method to prevent dental diseases as
      caries and periodontal problems in elderly but in the new National guidelines for dentistry
      there is pointed to that there are no scientific proof for the effect of professional oral
      care, besides ordinary daily oral care in grownups. This conclusion could not be translated
      to frail elderly who are dependent on help from the nursing staff to receive or perform daily
      oral hygiene. The effect of domiciliary oral care have to our knowledge, not been explored.
      This type of care can with rather simple equipments be performed with good quality, while
      more advanced dental care may present more 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.

      Aim:

      The aim is to develop and evaluate domiciliary prophylactic professional oral care. The
      researchers will compare the effect of different regimens for domiciliary prophylactic
      professional oral care on oral health in dependent elderly, both according to content and
      frequency. The overall aim is to to establish relevant recommendations for domiciliary
      prophylactic professional oral care.

      Project plan:

      Design:

      The project is designed as a randomised, double blind, clinical study with two parallel study
      arms. Randomisation is performed at group level (ward unit), blind for the researchers and
      participants (allocation concealment). Data analysis will be made on individual level but
      presented at group level. Appliance for Ethical permission has been made and approved for the
      first part of the study that already is performed but it has to be completed with an approval
      for the continuing part of the study.

      Pilot study:

      Before the main clinical study started, a pilot study was performed in three months (half the
      time of the main study) to test the relevance of the study protocol, sample size but also the
      possible difference in oral health effects of hands-on-work including professional oral care
      compared to information and instruction. The pilot study was performed with 96 individuals
      included that randomly received professional oral care by a dental hygienist each month,
      information and re-instruction about oral care together with their daily care staff each
      month or served as a control. They all received baseline and effect registrations but with a
      selected number of variables that covered the purpose with the pilot study.

      Participants The main study is planned to include 366 (2 x150 + 18 % compensation for
      estimated drop outs) dependent elderly individual in nursing homes. Inclusion criteria: at
      least 10 natural or fixed teeth inclusively osseointegrated implants, non smokers, ability to
      cooperate for oral assessment in 5-10 minutes and able to answer the Oral Health Related
      Quality of Life formula. Exclusion criteria: edentulousness and full dentures, cognitive
      limitations that is an obstacle for cooperation, malignancies and/or immunosuppressive
      diseases, coagulation defects. Anticoagulants will be registered but not as an exclusion
      criteria. The participants are consecutively recruited and sorted into the ward research
      group after informed consent - eventually with help of an advocate, (the ward research group
      is decided by chance when the first participant in the ward is recruited). A control group
      without any professional oral care during 6 months, will not be included in the main study,
      as it is not seen as good ethics to collect data without offer any oral care. Besides this,
      "ordinary care", either from the elderly themselves or nursing staff, vary. This is a
      confounding factor in the project that as far as possible is controlled by giving the same
      recommendations about routines for daily oral care to all included wards and participants. In
      accordance with ethical rules, the participants can interrupt their participation without
      explanation and negative consequences.

      Sample size and power estimation:

      The sample size is based on a power calculation of the least amount of individuals in each
      group to detect a significant difference of 7 % concerning bleeding at probing (BoP) between
      the groups (cluster randomisation in blocks on ward level to diminish unbalance in number of
      individuals in each ward), with risks for Type-I and Type-II estimated to alpha =0.05 and
      beta =0.20. For the primary effect variable, BoP (17), 150 individuals in each group are
      required. Due to high mortality in the study group (about 30 % in a year) and drop out
      because of illness, the sample will be increased with 18%. Accordingly, the number of
      participants will be n=366 (183 in each group). When drop outs, data analysis is performed
      due to intention-to-treat method.

      Intervention:

      All involved wards, nursing staff and relatives will be informed by a meeting where the
      project is presented and explained. At this occasion, a questionnaire will be distributed to
      the nursing staff to explore their knowledge and opinion about oral health care.

      Standard rules for the daily oral hygiene during the study period will be set out. As far as
      possible, the oral care circumstances should be similar on each included study ward. Products
      containing chlorhexidine will be set out two weeks before the study start.

      At baseline all participants will have an oral assessment together with a medical report
      including drug use, delivered by a registered nurse. On a subgroup consisting of 100
      individuals (50 in each study arm), the oral micro flora is measured through sampling
      collected from supra gingival plaque with sterile toothpicks. The total number of
      microorganisms growing and the proportion of a) lactobacilli and streptococcus mutans and b)
      opportunistic bacteria including Staphylococcus aureus and candida are calculated.

      As all participants is supposed to be eligible for free oral assessments at home and
      necessary dental care, their written oral care card will be updated with the routines that
      are actual during the study period. The exact performance of these routines will be
      established when the pilot study is evaluated.

      Intervention in the research groups is professional oral care with electric tooth brush
      (Braun Oral-B), "ordinary" fluoridated tooth paste (1100-1450 ppm NaF), and repeated oral
      care instruction to participants and staff (contact person) supra gingival depuration if
      necessary, fluor varnish and delivery of saliva stimulating and replacing products to
      participants that show a stimulated salivation less than 1,0 ml/minute. All groups are
      continued during a period of 12 months. If electric tooth brush not is tolerated, an ordinary
      suitable tooth brush, chosen by the dental hygienist, will be used. Group A receive treatment
      each month, Group B receive no additional treatment (control).

      Each participant is asked to brush their teeth every morning and evening with an "ordinary"
      fluoridated tooth paste (1100-1450 ppm NaF). Questions related to chewing ability and oral
      health related quality of life will be asked due to Geriatric Oral Health Assessment Index
      (GOHAI), as well as questions with the aim to evaluate how domiciliary professional oral care
      is experienced by the participants.

      Clinical registrations due to study protocol (see below: effect variables), are performed by
      calibrated dental staff (dentists or dental hygienists) at baseline, after three months and
      after six months in all three study groups.

      The dental staff will also have to get an opinion about the compliance of recommended
      routines and products with the help of questions to both the participants and the nursing
      staff. The exact construction of these questions will be made during the project period, as
      no validated formulas are available.

      A coordinator will be required to monitor the including researchers concerning their
      commitment to the study protocol and to handle unforeseeable events, like patient safety,
      complaints, complications. Any treatment complications that are suspected or reported, will
      be registred and the project leader act upon a relevant way. If any participant is in need of
      dental care besides what the project activities can supply, this will also be reported to and
      handled by the project leader.

      Effect variables:

      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 after three and each third month in
      both study groups. Comparison will be made on group level.

      Secondary effect variables: Manifest caries is registred with the tooth as analysis unit DT
      Measurements are performed at baseline and each third month in both study groups.

      Oral hygiene: Mucosal and plaque index, MPS, will be used both for fixed teeth and and
      partial removable dentures. The measurements are performed at baseline and each third month
      in both study groups..

      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 in both groups on the sub sample of 50 in each group.

      Tertiary effect variables: 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 in both groups.

      Oral Health Related Quality of Life will also be measured by GOHAI, at baseline and each six
      month.

      For the related nursing staff, two formulas will be used to measure knowledge about and
      attitudes to oral health, at baseline and each six month.

      Significance:

      Newly submitted data from professor Maude Wikström and her research group, inclusive main
      applicant Inger Wårdh, has pointed to that extensive oral hygiene routines may be effective
      in removing dental plaque but not opportunistic pathogens. This could probably be caused by
      oral dryness as the data also point to a need of stimulated flow at 1,0 ml/min before the
      pathogenic oral flora disappear, probably due to the self-cleaning effect of saliva. An
      important part of the professional oral health care would therefore be to supply with saliva
      stimulating or replacing products. Ongoing research also points to that we ought to use other
      products with the purpose to receive a higher pH-level in the oral cavity .It is lack of
      knowledge both according to content and frequency of professional oral care for dependent
      elderly and consequently neither how it ought to be subsidized from the government. However,
      in the first step it is important to create good routines for domiciliary professional oral
      care, which this project is able to do. The results will be published in scientific journals
      and also planned to be used in a PhD thesis and two master thesis.
    

Intervention name(s): Intervention
Intervention type(s): Other
Intervention description(s): Professional oral care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: elderly; oral care