Oral Hygiene Intervention Pilot Study
Condition: Dental Caries; Gingivitis
MeSH terms: Gingivitis; Dental Caries
Study type: Interventional

Summary: 
      The main goals of this pilot study are to develop a nursing home-customized oral hygiene
      protocol, intended to be delivered primarily by dental hygienists and primary care providers,
      and to identify potential obstacles and barriers to overcome in designing a subsequent
      definitive study on the same topic.
    

Detailed description: 
      For the purposes of this pilot study, a convenience sample from six (6) to twelve (12)
      nursing facilities will be selected and randomly assigned into three groups: Experimental
      group 1 (educational program only, performed by a dental hygienist); Experimental group 2
      (educational program plus 1% chlorhexidine varnish application monthly for the residents);
      Control group (current oral hygiene practice). Several objective and subjective oral and
      general health measures will be observed before and after the interventions to evaluate the
      impact of the interventions on the oral and general health of the residents and also of the
      direct care workers.

      Assigned personnel in each nursing facility (NF) will be interviewed to identify possible
      barriers to provide oral care. Each interview will take one hour, approximately.

      All residents that agree to participate will be interviewed and have an oral examination and
      dental plaque sample collection by the investigators. Each appointment will take 30 minutes.
      The subject's health record in the nursing facilities will be abstracted for medical
      information (date of birth, sex, race, source of payment for NF residency, comorbid
      conditions, weight, height, medications, number of febrile days, and x-ray documented
      pneumonia episodes).

      After that, the educational program will be delivered in a standardized fashion for all NF in
      the "educational program only group": 1) Cognitively capable residents will receive
      instruction on how to perform their own oral hygiene accordingly to their own needs
      (approximately 15 minutes); and 2) Direct care workers will receive instruction on how to
      perform oral hygiene for dependent residents or supervise the oral hygiene routines of
      independent patients (01 hour session). For both 1) and 2) above, dental hygienists will
      provide a short, standardized presentation and hands-on demonstration. In addition, the
      dental hygienist will provide in situ oral care (plaque and gingival bleeding index
      assessment, microbiological sampling and toothbrushing with chlorhexidine mouth rinse) on a
      bi-weekly basis during the study period (15 minute each appointment) .

      The "educational program plus 1% chlorhexidine varnish application group" will receive the
      educational program described above. In addition, residents who need supervision or are
      unable to perform oral hygiene procedures will receive 1% chlorhexidine varnish application
      monthly by the dental hygienist. No additional time commitment will be necessary.The direct
      care workers will NOT receive any varnish.

      The control group will not receive any intervention through this protocol during the formal
      study period, but if the initial results are promising they will be invited after the formal
      study period to receive the educational program.

      After a six month period from the initial examination,all residents and direct care workers
      that agree to participate will be interviewed and have an oral examination and dental plaque
      sample collection by the investigators again. Each appointment will take 30 minutes.
    

Intervention name(s): oral health assessment; Questionnaires; Clinical Exam; Microbiological sampling; Monitoring Adherence; Varnish application; Consent; Educational Program
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): A baseline oral health assessment of both residents and direct care workers will be conducted before interventions are initiated. Data will be entered directly into a spreadsheet format using the chairside software program to be developed as part of this proposal.; Age, sex, race, nutrition (mini-nutri), quality of life (SF-36), OHIP-14, GOHAI, sources of payment for the NF residency, comorbid conditions (e.g., constipation, arthritis), weight, medications, cognitive status (mini-mental) , dry mouth sensation, x-ray documented pneumonia;; Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;; Samples will be collected by swabbing patients intra-oral tissues. Samples will be separately collected from dentures and oral tissues for edentulous patients, also using swabs. All samples will be suspended in saline solution.; Adherence to the protocol will be evaluated through unannounced observations at the NF by study personnel twice per month. Adherence is determined by direct observation of the DCW administering the intervention.; 1% chlorhexidine varnish application group" will receive the educational program described above. In addition, residents who need supervision or are unable to perform oral hygiene procedures will receive 1% chlorhexidine varnish application monthly by the dental hygienist. No additional time commitment will be necessary.The direct care workers will NOT receive any varnish.; Both the residents and primary care workers will be asked to participate on the study, and the investigators will provide information and collect signed informed consents primarily during two in person visits to each nursing facilities.; Cognitively capable residents will receive instruction on how to perform their own oral hygiene accordingly to their own needs; and 2) Direct care workers will receive instruction on how to perform oral hygiene for dependent residents or supervise the oral hygiene routines of independent patients. For both 1) and 2) above, dental hygienists will provide a short, standardized presentation and hands-on demonstration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research