Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2014-06-30
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Experimental Group 1
consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.
oral health assessment
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.
Questionnaires
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;
Clinical Exam
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Microbiological sampling
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.
Monitoring Adherence
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.
Consent
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.
Educational Program
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.
Experimental group 2
Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application
oral health assessment
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.
Questionnaires
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;
Clinical Exam
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Microbiological sampling
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.
Monitoring Adherence
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.
Varnish application
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.
Consent
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.
Educational Program
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.
Control Group
Consent,clinical exam, microbiological sampling, questionnaires
oral health assessment
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.
Questionnaires
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;
Clinical Exam
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Microbiological sampling
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.
Consent
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.
Interventions
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oral health assessment
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.
Questionnaires
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;
Clinical Exam
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Microbiological sampling
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.
Monitoring Adherence
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.
Varnish application
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.
Consent
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.
Educational Program
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.
Eligibility Criteria
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Inclusion Criteria
* age 21-120
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
21 Years
120 Years
ALL
Yes
Sponsors
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Ivoclar Vivadent AG
INDUSTRY
Delta Dental of Iowa
OTHER
Leonardo Marchini
OTHER
Responsible Party
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Leonardo Marchini
DDS
Principal Investigators
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Brad Amendt, MS
Role: STUDY_DIRECTOR
UIowa College of Dentistry
Locations
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UIowa
Iowa City, Iowa, United States
Countries
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Other Identifiers
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INFOH
Identifier Type: -
Identifier Source: org_study_id
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