Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 60 - 85 |
| Updated: | 10/10/2018 |
| Start Date: | June 1, 2018 |
| End Date: | December 31, 2018 |
| Contact: | Emily Stein, PhD |
| Email: | emily.stein@primaltx.com |
| Phone: | 510-847-8132 |
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.
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.
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.
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.
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).
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).
We found this trial at
1
site
Click here to add this to my saved trials
