Clinical trial NCT02668809: Oral Hygiene Intervention Pilot Study
Official title: Iowa Nursing Facility Oral Hygiene Intervention: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Gingivitis
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Ivoclar Vivadent AG
name: Delta Dental of Iowa
First posted: 2016-01-29
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* be a resident or primary care worker in one of the following nursing homes: Linn Manor Care Center Simpson Memorial Home, Inc., Wilton Retirement Community, All-American Care of Muscatine, Pioneer Park of Lone Tree, Colonial Manor of the Columbus Community, Sunrise Terrace Nursing and Rehabilitation Center Parkview Home-Wayland.
* age 21-120

Exclusion criteria:

Only those who do not sign the consent form will be excluded

Exclusion Criteria:

* not a resident or primary care worker in one of the above listed retirement homes
* age less than 21 or greater than 110

Primary outcomes:
measure: Plaque index
timeFrame: 6 months
measure: Denture plaque index
timeFrame: 6 months
measure: Gingival bleeding index
timeFrame: 6 months
measure: Decayed, missing or filled surfaces (DMFS) index
timeFrame: 6 months
measure: Total microbial count
timeFrame: 6 months
measure: Isolation and enumeration of our target species: Porphyromonas gingivalis, Prevotella intermedia, Methicillin-Resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Actinomyces spp., Fusobacterium nucleatum, and Candida albicans.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of residents cognitive status using Mini Cog test
timeFrame: 6 months
measure: Assessment of cognitively sound participants quality of life using SF-36 questionnaire
timeFrame: 6 months
measure: Assessment of cognitively sound participants oral health-related quality of life using OHIP 14
timeFrame: 6 months
measure: Assessment of cognitively sound geriatric participants oral health-related quality of life using GOHAI
timeFrame: 6 months
measure: Assessment of participants nutritional status using Mini Nutritional Assessment Short Form
timeFrame: 6 months
measure: Assessment of number of events of x-ray documented pneumonia
timeFrame: 6 months
measure: Assessment of number of febrile days
timeFrame: 6 months
measure: Assessment of dry mouth sensation
timeFrame: 6 months
measure: Assessment of the presence of oral lesions
timeFrame: 6 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: UIowa
state: Iowa
Study officials:
affiliation: UIowa College of Dentistry
name: Brad Amendt, MS
role: STUDY_DIRECTOR
References: