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

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追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 2, 2018

最后更新发布日期

October 2, 2018

预计研究开始日期 ^ICMJE

June 1, 2018

预计主要完成日期

December 20, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change from Baseline of Bacterial Burden[ Time Frame: Measured at baseline and at 6 weeks ]

Oral swabs and oral mouth rinses will be taken from subjects. Bacterial burden and composition will be determined by live bacterial cultures and quantitative polymerase chain reaction.

Change from Baseline of oral health[ Time Frame: Measured at baseline and at 6 weeks ]

Oral gum health and dental assessments including modified gingival index will be determined by a licensed dental practitioner.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Change from Baseline in oral health behaviors and habits[ Time Frame: Measured at baseline and at 6 weeks ]
Subjects are asked a comprehensive questionnaire regarding overall medical and dental health as well as oral and dental care habits and behaviors

描述性信息

简略标题 ^ICMJE

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

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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. We believe we have a cost-effective, nontoxic and easy-to-take oral solution in PTx800 rapid dissolving lozenges. We are evaluating the performance and ease of use in the older adult population who frequent elderly community centers in the greater Cleveland, Ohio area. We will assess the 6-week efficacy of PTx800 vs a placebo control as supplements to standard oral hygiene practices in a group of participants who have mild to moderate gingivitis, and compare the change in oral health outcomes and pathogen burdens over time. As a part of the study design, we will also survey this population for perceptions, biases and habits as they relate to oral health, social and emotional well-being. The culmination of this work will enable us to better understand and address the oral health crisis in older adults, as well as to evaluate the impact our approach may have in improving quality of life for this demographic.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

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.

研究工具

Experimental: cohort 1
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.
Placebo Comparator: cohort 2
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.

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 31, 2018

预计主要完成日期

December 20, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - (i) age range between 60 and 85 years, (ii) Non-smokers or those who have stopped for 2 years or more. (iii) A baseline gingival index (MGI score greater or equal to 1.75) (iii) A score of 4 or lower on the Short Portable Mental Status Questionnaire (SPMSQ) Exclusion Criteria: - (i) Subjects on antibiotic within the previous 30 days (ii) Fixed or removable full or partial dentures (iii) Advanced periodontitis (iv) Significant oral soft tissue pathology based on a visual examination (excluding gingivitis) (v) Gross dental caries. (vi) A score of 5 or higher on the Short Portable Mental Status Questionnaire (SPMSQ).

性别

参与研究的性别:

All

年龄

最小年龄：60 Years ，最大年龄：85 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Primal Therapies Inc.

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Emily Stein Primal Therapies

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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