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临床试验/NCT02668809
NCT02668809已完成不适用

Iowa Nursing Facility Oral Hygiene Intervention: A Pilot Study

Leonardo Marchini2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
Denture plaque index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: oral health assessment (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Questionnaires (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Clinical Exam (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Microbiological sampling (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Monitoring Adherence (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Consent (Other)

Experimental Group 1

Experimental

consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.

干预措施: Educational Program (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: oral health assessment (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Questionnaires (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Clinical Exam (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Microbiological sampling (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Monitoring Adherence (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Varnish application (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Consent (Other)

Experimental group 2

Experimental

Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application

干预措施: Educational Program (Other)

Control Group

Placebo Comparator

Consent,clinical exam, microbiological sampling, questionnaires

干预措施: oral health assessment (Other)

Control Group

Placebo Comparator

Consent,clinical exam, microbiological sampling, questionnaires

干预措施: Questionnaires (Other)

Control Group

Placebo Comparator

Consent,clinical exam, microbiological sampling, questionnaires

干预措施: Clinical Exam (Other)

Control Group

Placebo Comparator

Consent,clinical exam, microbiological sampling, questionnaires

干预措施: Microbiological sampling (Other)

Control Group

Placebo Comparator

Consent,clinical exam, microbiological sampling, questionnaires

干预措施: Consent (Other)

结局指标

主要结局

Denture plaque index

时间窗: 6 months

Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.

Plaque index

时间窗: 6 months

Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.

Gingival bleeding index

时间窗: 6 months

Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.

Decayed, missing or filled surfaces (DMFS) index

时间窗: 6 months

Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.

Total microbial count

时间窗: 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.

时间窗: 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.

次要结局

  • Assessment of cognitively sound participants quality of life using SF-36 questionnaire(6 months)
  • Assessment of residents cognitive status using Mini Cog test(6 months)
  • Assessment of participants nutritional status using Mini Nutritional Assessment Short Form(6 months)
  • Assessment of cognitively sound participants oral health-related quality of life using OHIP 14(6 months)
  • Assessment of cognitively sound geriatric participants oral health-related quality of life using GOHAI(6 months)
  • Assessment of number of events of x-ray documented pneumonia(6 months)
  • Assessment of number of febrile days(6 months)
  • Assessment of dry mouth sensation(6 months)
  • Assessment of the presence of oral lesions(6 months)

研究者

发起方
Leonardo Marchini
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leonardo Marchini

DDS

University of Iowa

研究点 (2)

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