Oral Hygiene Intervention Pilot Study

NCT02668809 | Completed

• 1 other identifier: INFOH
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Gingivitis

Outcome Measures

Primary Outcomes (6)

• Plaque index

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

  6 months

• Denture plaque index

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

  6 months

• Gingival bleeding index

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

  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.

  6 months

• Total microbial count

  Numbers of viable bacteria per swab will be determined following sector counting and analysis following standard spiral plating methodology

  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.

  6 months

Secondary Outcomes (9)

• Assessment of residents cognitive status using Mini Cog test

  6 months

• Assessment of cognitively sound participants quality of life using SF-36 questionnaire

  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 participants nutritional status using Mini Nutritional Assessment Short Form

  6 months

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

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

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

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

Other: oral health assessment; Other: Questionnaires; Other: Clinical Exam; Other: Microbiological sampling; Other: Consent

Interventions

oral health assessment OTHER

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.

Control Group; Experimental Group 1; Experimental group 2

Questionnaires OTHER

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;

Control Group; Experimental Group 1; Experimental group 2

Clinical Exam OTHER

Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;

Control Group; Experimental Group 1; Experimental group 2

Microbiological sampling OTHER

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.

Control Group; Experimental Group 1; Experimental group 2

Monitoring Adherence OTHER

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.

Experimental Group 1; Experimental group 2

Varnish application OTHER

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.

Experimental group 2

Consent OTHER

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.

Control Group; Experimental Group 1; Experimental group 2

Educational Program OTHER

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.

Experimental Group 1; Experimental group 2

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leonardo Marchini: lead
• Ivoclar Vivadent AG: collaborator
• Delta Dental of Iowa: collaborator

Study Sites (1)

UIowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Dental Caries; Gingivitis

Interventions

Surveys and Questionnaires; Consent Forms

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Informed Consent; Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Records; Organization and Administration; Health Services Administration

Study Officials

• Brad Amendt, MS

  UIowa College of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 29, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

US (1)