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Oral Hygiene Intervention Pilot Study

Primary Purpose

Dental Caries, Gingivitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oral health assessment
Questionnaires
Clinical Exam
Microbiological sampling
Monitoring Adherence
Varnish application
Consent
Educational Program
Sponsored by
Leonardo Marchini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dental Caries

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UIowa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Experimental Group 1

Experimental group 2

Control Group

Arm Description

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

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

Consent,clinical exam, microbiological sampling, questionnaires

Outcomes

Primary Outcome Measures

Plaque index
Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.
Denture plaque index
Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.
Gingival bleeding index
Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.
Decayed, missing or filled surfaces (DMFS) index
Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.
Total microbial count
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.
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

Assessment of residents cognitive status using Mini Cog test
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 cognitively sound participants quality of life using SF-36 questionnaire
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 cognitively sound participants oral health-related quality of life using OHIP 14
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
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 participants nutritional status using Mini Nutritional Assessment Short Form
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 number of events of x-ray documented pneumonia
X-ray documented pneumonia events are assessed through medical records at baseline and end of the experiment protocol.
Assessment of number of febrile days
Number of febrile days are assessed through medical records at baseline and end of the experiment protocol.
Assessment of dry mouth sensation
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
Presence of oral lesions was assessed by clinical exam at baseline and by the end of the experimental protocol

Full Information

First Posted
January 22, 2016
Last Updated
August 27, 2018
Sponsor
Leonardo Marchini
Collaborators
Ivoclar Vivadent AG, Delta Dental of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT02668809
Brief Title
Oral Hygiene Intervention Pilot Study
Official Title
Iowa Nursing Facility Oral Hygiene Intervention: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leonardo Marchini
Collaborators
Ivoclar Vivadent AG, Delta Dental of Iowa

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Gingivitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence.
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Consent,clinical exam, microbiological sampling, questionnaires
Intervention Type
Other
Intervention Name(s)
oral health assessment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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;
Intervention Type
Other
Intervention Name(s)
Clinical Exam
Intervention Description
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Intervention Type
Other
Intervention Name(s)
Microbiological sampling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Monitoring Adherence
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Varnish application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Consent
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque index
Description
Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.
Time Frame
6 months
Title
Denture plaque index
Description
Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.
Time Frame
6 months
Title
Gingival bleeding index
Description
Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.
Time Frame
6 months
Title
Decayed, missing or filled surfaces (DMFS) index
Description
Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.
Time Frame
6 months
Title
Total microbial count
Description
Numbers of viable bacteria per swab will be determined following sector counting and analysis following standard spiral plating methodology
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Assessment of residents cognitive status using Mini Cog test
Description
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.
Time Frame
6 months
Title
Assessment of cognitively sound participants quality of life using SF-36 questionnaire
Description
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.
Time Frame
6 months
Title
Assessment of cognitively sound participants oral health-related quality of life using OHIP 14
Description
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.
Time Frame
6 months
Title
Assessment of cognitively sound geriatric participants oral health-related quality of life using GOHAI
Description
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.
Time Frame
6 months
Title
Assessment of participants nutritional status using Mini Nutritional Assessment Short Form
Description
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.
Time Frame
6 months
Title
Assessment of number of events of x-ray documented pneumonia
Description
X-ray documented pneumonia events are assessed through medical records at baseline and end of the experiment protocol.
Time Frame
6 months
Title
Assessment of number of febrile days
Description
Number of febrile days are assessed through medical records at baseline and end of the experiment protocol.
Time Frame
6 months
Title
Assessment of dry mouth sensation
Description
Participants are asked about feeling their mouth dry at baseline and by the end of the experimental protocol
Time Frame
6 months
Title
Assessment of the presence of oral lesions
Description
Presence of oral lesions was assessed by clinical exam at baseline and by the end of the experimental protocol
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Amendt, MS
Organizational Affiliation
UIowa College of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
UIowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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