NCT03693027

Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Primal Therapies Inc. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Oral Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PTx800 lozenges	PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
DIETARY_SUPPLEMENT	Placebo control	The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.

Timeline

• Start date: 2018-06-01
• Primary completion: 2018-12-20
• Completion: 2018-12-31
• First posted: 2018-10-02
• Last updated: 2018-10-09

Locations

1 site across 1 country: United States