Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults
NCT ID: NCT03693027
Last Updated: 2018-10-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-06-01
Study Completion Date
2018-12-31
Brief Summary
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The assessment of a daily oral care lozenge (PTx800) will be compared to a placebo control in a cohort of older adults who visit adult senior centers and who also have mild to moderate gingivitis. The comparison of the pre-to post change in gum health and pathogen burdens will be measured over a 6 week period. In addition, the feasibility and acceptability of using the lozenges will be assessed in this older adult population.
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Detailed Description
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By 2030, 70 million Americans will be over the age of 65. Currently, 70% of older adults have periodontal disease, 20% have untreated tooth decay, and 1 in 4 older adults have lost some or all of their teeth. This poses a significant problem as mounting evidence demonstrates a link between oral disease and life-threatening diseases, including premature death. Gum disease is associated with systemic conditions such as cardiovascular disease, stroke, diabetes mellitus, chronic kidney disease, respiratory disorders, dementia and cancers. Moreover, numerous studies suggest that the number of teeth lost in adulthood is a predictor of premature death. Therefore, an individual's oral health and general health are tightly linked and good oral hygiene could be an easy means of preventing serious, life-threatening conditions in many older adults.
For many older adults, decreased manual dexterity, physical or mental impairment, income constraints, lack of dental insurance, all contribute to and exacerbate oral disease. A cost-effective, nontoxic and easy-to-take oral solution has been developed; PTx800 rapid dissolving lozenges. The investigators are evaluating PTx800 lozenge performance on gum health and ease of use in the older adult population who frequent community centers in the greater Cleveland, Ohio area. Efficacy assessment will be determined over the course of 6 weeks on participants with confirmed mild-to-moderate gingivitis. Endpoint measurements on gum health for PTx800 vs placebo control will be evaluated. Furthermore, the ease of use and receptivity to the PTx800 lozenges will be assessed in order to determine whether the PTx800 lozenges could be a viable candidate to supplement standard oral hygiene practices. A comparison in the change in oral health outcomes and dental pathogen burdens will be investigated in the 6-week study. As a part of the study design, a survey of this population will be conducted to understand perceptions, biases and habits as they relate to oral health, social and emotional well-being. The culmination of this work will impart a better understanding of, and facilitate appropriate actions to address, the oral health crisis in older adults. The ultimate goal of this study is to identify methods to improve the quality of life for this demographic.
For many older adults, decreased manual dexterity, physical or mental impairment, income constraints, lack of dental insurance, all contribute to and exacerbate oral disease. A cost-effective, nontoxic and easy-to-take oral solution has been developed; PTx800 rapid dissolving lozenges. The investigators are evaluating PTx800 lozenge performance on gum health and ease of use in the older adult population who frequent community centers in the greater Cleveland, Ohio area. Efficacy assessment will be determined over the course of 6 weeks on participants with confirmed mild-to-moderate gingivitis. Endpoint measurements on gum health for PTx800 vs placebo control will be evaluated. Furthermore, the ease of use and receptivity to the PTx800 lozenges will be assessed in order to determine whether the PTx800 lozenges could be a viable candidate to supplement standard oral hygiene practices. A comparison in the change in oral health outcomes and dental pathogen burdens will be investigated in the 6-week study. As a part of the study design, a survey of this population will be conducted to understand perceptions, biases and habits as they relate to oral health, social and emotional well-being. The culmination of this work will impart a better understanding of, and facilitate appropriate actions to address, the oral health crisis in older adults. The ultimate goal of this study is to identify methods to improve the quality of life for this demographic.
Conditions
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Oral Health
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
OTHER
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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PTx800
Qualified subjects will dissolve one oral lozenge (PTx800 lozenges) by mouth 3 times a day (after breakfast, lunch and dinner) throughout the 6 week study.
Group Type
EXPERIMENTAL
PTx800 lozenges
Intervention Type
DIETARY_SUPPLEMENT
PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
Placebo
Qualified subjects will dissolve one oral lozenge (placebo control) by mouth 3 times a day (after breakfast, lunch and dinner) throughout the 6 week study.
Group Type
PLACEBO_COMPARATOR
Placebo control
Intervention Type
DIETARY_SUPPLEMENT
The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.
Interventions
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PTx800 lozenges
PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
Intervention Type
DIETARY_SUPPLEMENT
Placebo control
The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* age range between 60 and 85 years,
* non-smokers or those who have stopped for 2 years or more,
* baseline gingival index (MGI score greater or equal to 1.75),
* score of 4 or lower on the Short Portable Mental Status Questionnaire (SPMSQ).
* non-smokers or those who have stopped for 2 years or more,
* baseline gingival index (MGI score greater or equal to 1.75),
* score of 4 or lower on the Short Portable Mental Status Questionnaire (SPMSQ).
Exclusion Criteria
* subjects on antibiotic within the previous 30 days,
* fixed or removable full dentures,
* advanced periodontitis,
* significant oral soft tissue pathology based on a visual examination (excluding gingivitis),
* gross dental caries,
* score of 5 or higher on the Short Portable Mental Status Questionnaire (SPMSQ).
* fixed or removable full dentures,
* advanced periodontitis,
* significant oral soft tissue pathology based on a visual examination (excluding gingivitis),
* gross dental caries,
* score of 5 or higher on the Short Portable Mental Status Questionnaire (SPMSQ).
Minimum Eligible Age
60 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Benjamin Rose Institute on Aging
OTHER
Sponsor Role
collaborator
Primal Therapies Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Emily Stein
Role: PRINCIPAL_INVESTIGATOR
Primal Therapies
Locations
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Benjamin Rose Institute on Aging
Cleveland, Ohio, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2017-04
Identifier Type: -
Identifier Source: org_study_id
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