Dental CariesNCT02668809
Oral Hygiene Intervention Pilot Study
A study testing oral health assessment, Questionnaires and Clinical Exam in people with Dental Caries and Gingivitis, run by Leonardo Marchini at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Gingivitis
- What is being tested?
- oral health assessment, Questionnaires and Clinical Exam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iowa Nursing Facility Oral Hygiene Intervention: A Pilot Study
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.
Read the 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.
- Conditions
- Dental Caries, Gingivitis
- Being tested
- oral health assessment, Questionnaires, Clinical Exam, Microbiological sampling, Monitoring Adherence
- Medical subject headings
- Dental Caries, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral health assessmentOther
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.
QuestionnairesOther
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 ExamOther
Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
Microbiological samplingOther
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 AdherenceOther
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 applicationOther
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.
ConsentOther
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 ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. Receives: Other: oral health assessment; Other: Questionnaires; Other: Clinical Exam; Other: Microbiological sampling; Other: Monitoring Adherence; Other: Consent; Other: Educational Program |
| Experimental group 2 | Experimental | Consent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application Receives: Other: oral health assessment; Other: Questionnaires; Other: Clinical Exam; Other: Microbiological sampling; Other: Monitoring Adherence; Other: Varnish application; Other: Consent; Other: Educational Program |
| Control Group | Placebo comparator | Consent,clinical exam, microbiological sampling, questionnaires Receives: Other: oral health assessment; Other: Questionnaires; Other: Clinical Exam; Other: Microbiological sampling; Other: Consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.
Measured: 6 months
Denture plaque index
Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.
Measured: 6 months
Gingival bleeding index
Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.
Measured: 6 months
Decayed, missing or filled surfaces (DMFS) index
Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.
Measured: 6 months
Total microbial count
Numbers of viable bacteria per swab will be determined following sector counting and analysis following standard spiral plating methodology
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (9)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Assessment of number of febrile days
Number of febrile days are assessed through medical records at baseline and end of the experiment protocol.
Measured: 6 months
Assessment of dry mouth sensation
Participants are asked about feeling their mouth dry at baseline and by the end of the experimental protocol
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonardo Marchini
- Sponsor type
- University, hospital or other
- Collaborators
- Ivoclar Vivadent AG, Delta Dental of Iowa
- Responsible party
- Sponsor-investigator, Leonardo Marchini, University of Iowa
- Investigators
- Brad Amendt, MS, Study director, UIowa College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668809
- Sponsor's protocol ID
- INFOH
- Status last verified
- Aug 2018
- First submitted
- 22 Jan 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Nursing Facility Oral Hygiene Intervention: A Pilot Study
- ClinicalTrials.gov ID
- NCT02668809
- Acronym / sponsor ID
- INFOH
- Conditions
- Dental Caries, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Leonardo MarchiniUniversity, hospital or other
- Collaborators
- Ivoclar Vivadent AG, Delta Dental of Iowa
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: oral health assessment, Other: Questionnaires, Other: Clinical Exam, Other: Microbiological sampling, Other: Monitoring Adherence, Other: Consent, Other: Educational Programconsent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence. |
| Experimental group 2 | Experimental | Other: oral health assessment, Other: Questionnaires, Other: Clinical Exam, Other: Microbiological sampling, Other: Monitoring Adherence, Other: Varnish application, Other: Consent, Other: Educational ProgramConsent, oral health assessment, questionnaires, Educational Program, clinical exam, microbiological sampling, monitoring adherence, varnish application |
| Control Group | Placebo comparator | Other: oral health assessment, Other: Questionnaires, Other: Clinical Exam, Other: Microbiological sampling, Other: ConsentConsent,clinical exam, microbiological sampling, questionnaires |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral health assessmentA 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. | Other | Control Group, Experimental Group 1, Experimental group 2 |
| QuestionnairesAge, 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; | Other | Control Group, Experimental Group 1, Experimental group 2 |
| Clinical ExamDentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness; | Other | Control Group, Experimental Group 1, Experimental group 2 |
| Microbiological samplingSamples 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. | Other | Control Group, Experimental Group 1, Experimental group 2 |
| Monitoring AdherenceAdherence 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. | Other | Experimental Group 1, Experimental group 2 |
| Varnish application1% 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. | Other | Experimental group 2 |
| ConsentBoth 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. | Other | Control Group, Experimental Group 1, Experimental group 2 |
| Educational ProgramCognitively 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. | Other | Experimental Group 1, Experimental group 2 |
Primary outcome
Plaque index
Time frame: 6 months
Percentage reflecting the proportion of teeth surfaces covered by plaque, assessed by intra-oral exam.
Denture plaque index
Time frame: 6 months
Index reflecting the proportion of denture surfaces covered by plaque, assessed by denture exam.
Gingival bleeding index
Time frame: 6 months
Index reflecting the proportion of gingival areas Bleeding on probing, assessed by intra-oral exam.
Decayed, missing or filled surfaces (DMFS) index
Time frame: 6 months
Index reflecting the number of decayed, missing or filled teeth surfaces, assessed by intra-oral exam.
Total microbial count
Time frame: 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.
Time frame: 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.
9 secondary outcomes
Assessment of residents cognitive status using Mini Cog test
Time frame: 6 months
Assessment of cognitively sound participants quality of life using SF-36 questionnaire
Time frame: 6 months
Assessment of cognitively sound participants oral health-related quality of life using OHIP 14
Time frame: 6 months
Assessment of cognitively sound geriatric participants oral health-related quality of life using GOHAI
Time frame: 6 months
Assessment of participants nutritional status using Mini Nutritional Assessment Short Form
Time frame: 6 months
Assessment of number of events of x-ray documented pneumonia
Time frame: 6 months
Assessment of number of febrile days
Time frame: 6 months
Assessment of dry mouth sensation
Time frame: 6 months
Assessment of the presence of oral lesions
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Amendt, MS study director
UIowa College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral health assessment, Questionnaires and Clinical Exam in people with Dental Caries and Gingivitis, run by Leonardo Marchini at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.