Oral Hygiene Intervention Pilot Study
- Conditions
- GingivitisDental Caries
- Interventions
- Other: oral health assessmentOther: QuestionnairesOther: Clinical ExamOther: Microbiological samplingOther: Monitoring AdherenceOther: ConsentOther: Varnish applicationOther: Educational Program
- Registration Number
- NCT02668809
- Lead Sponsor
- Leonardo Marchini
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- not a resident or primary care worker in one of the above listed retirement homes
- age less than 21 or greater than 110
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group 1 Questionnaires consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental Group 1 Microbiological sampling consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Control Group Questionnaires Consent,clinical exam, microbiological sampling, questionnaires Experimental Group 1 Consent consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental Group 1 Educational Program consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental group 2 Monitoring Adherence Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Control Group Clinical Exam Consent,clinical exam, microbiological sampling, questionnaires Experimental Group 1 Clinical Exam consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental Group 1 Monitoring Adherence consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental group 2 oral health assessment Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Experimental group 2 Varnish application Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Control Group oral health assessment Consent,clinical exam, microbiological sampling, questionnaires Experimental Group 1 oral health assessment consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Experimental group 2 Clinical Exam Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Control Group Consent Consent,clinical exam, microbiological sampling, questionnaires Control Group Microbiological sampling Consent,clinical exam, microbiological sampling, questionnaires Experimental group 2 Questionnaires Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Experimental group 2 Microbiological sampling Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Experimental group 2 Consent Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Experimental group 2 Educational Program Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application
- Primary Outcome Measures
Name Time Method Plaque index 6 months Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.
Denture plaque index 6 months Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.
Gingival bleeding index 6 months Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.
Decayed, missing or filled surfaces (DMFS) index 6 months Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.
Total microbial count 6 months Numbers of viable bacteria per swab will be determined following sector counting and analysis following standard spiral plating methodology
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. 6 months Plates will be counted following standard incubation times for each group of organisms and numbers of viable bacteria per swab will be determined following sector counting and analysis following standard spiral plating methodology.
- Secondary Outcome Measures
Name Time Method Assessment of cognitively sound participants quality of life using SF-36 questionnaire 6 months The Short Form (36) Health Survey is a 36-item, patient-reported survey about quality of life. The instruments will be applied at baseline and end of the experiment protocol.
Assessment of residents cognitive status using Mini Cog test 6 months Mini-Cog test is a 3-minute instrument to screen for cognitive impairment in older adults in the primary care setting.The instruments will be applied at baseline and end of the experiment protocol.
Assessment of participants nutritional status using Mini Nutritional Assessment Short Form 6 months The Mini Nutritional Assessment Short Form is a short questionnaire that also considers the BMI (weight in kg/height in m2) and provides an estimate of an individuals nutritional state. The instruments will be applied at baseline and end of the experiment protocol.
Assessment of cognitively sound participants oral health-related quality of life using OHIP 14 6 months Oral Health Impact Profile 14 questions questionnaire (OHIP-14) is a validated, commonly used, comprehensive questionnaire about oral-health related quality of life. The instruments will be applied at baseline and end of the experiment protocol.
Assessment of cognitively sound geriatric participants oral health-related quality of life using GOHAI 6 months The Geriatric Oral Health Assessment Index (GOHAI) is a validated, widely used questionnaire developed to assess oral health perceptions among geriatric populations.The instruments will be applied at baseline and end of the experiment protocol.
Assessment of number of events of x-ray documented pneumonia 6 months X-ray documented pneumonia events are assessed through medical records at baseline and end of the experiment protocol.
Assessment of number of febrile days 6 months Number of febrile days are assessed through medical records at baseline and end of the experiment protocol.
Assessment of dry mouth sensation 6 months Participants are asked about feeling their mouth dry at baseline and by the end of the experimental protocol
Assessment of the presence of oral lesions 6 months Presence of oral lesions was assessed by clinical exam at baseline and by the end of the experimental protocol
Trial Locations
- Locations (1)
UIowa
🇺🇸Iowa City, Iowa, United States