Oral Hygiene Intervention Pilot Study

L

Leonardo Marchini

Status

Completed

Conditions

Dental Caries
Gingivitis

Treatments

Other: oral health assessment
Other: Questionnaires
Other: Consent
Other: Microbiological sampling
Other: Monitoring Adherence
Other: Clinical Exam
Other: Educational Program
Other: Varnish application

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02668809
INFOH

Details and patient eligibility

About

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.

Full 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.

Enrollment

81 patients

Sex

All

Ages

21 to 120 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 3 patient groups, including a placebo group

Experimental Group 1
Experimental group
Description:
consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.
Treatment:
Other: Educational Program
Other: Clinical Exam
Other: Monitoring Adherence
Other: Microbiological sampling
Other: Consent
Other: Questionnaires
Other: oral health assessment
Experimental group 2
Experimental group
Description:
Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application
Treatment:
Other: Educational Program
Other: Varnish application
Other: Clinical Exam
Other: Monitoring Adherence
Other: Microbiological sampling
Other: Consent
Other: Questionnaires
Other: oral health assessment
Control Group
Placebo Comparator group
Description:
Consent,clinical exam, microbiological sampling, questionnaires
Treatment:
Other: Clinical Exam
Other: Microbiological sampling
Other: Consent
Other: Questionnaires
Other: oral health assessment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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