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

Sponsor

Primal Therapies Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03693027

Collaborator

Benjamin Rose Institute on Aging (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Health	Dietary Supplement: PTx800 lozenges Dietary Supplement: Placebo control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2018

Anticipated Primary Completion Date :

Dec 20, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: PTx800 lozenges PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
Placebo Comparator: 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.	Dietary Supplement: Placebo control The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: PTx800 lozenges

PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.

Placebo Comparator: 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.

Dietary Supplement: Placebo control

The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.

Outcome Measures

Primary Outcome Measures

Change from Baseline of Bacterial Burden [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 [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. The Modified Gingival Index (MGI) uses non-invasive/no probing methods. The scoring system rates mild and moderate inflammation where: 0 = no inflammation; 1 = mild inflammation or with slight changes in color and texture in a portion of gingival tissue; 2 = mild inflammation in all portions of the gingiva; 3 = moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary; 4 = severe inflammation: erythema, edema and/or marginal gingival hypertrophy or spontaneous bleeding, papillary, congestion or ulceration.

Secondary Outcome Measures

Change from Baseline in oral health behaviors and habits [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benjamin Rose Institute on Aging	Cleveland	Ohio	United States	44120

Sponsors and Collaborators

Primal Therapies Inc.
Benjamin Rose Institute on Aging

Investigators

Principal Investigator: Emily Stein, Primal Therapies

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Primal Therapies Inc.

ClinicalTrials.gov Identifier:

NCT03693027

Other Study ID Numbers:

2017-04

First Posted:

Oct 2, 2018

Last Update Posted:

Oct 9, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Primal Therapies Inc.

Study Results

No Results Posted as of Oct 9, 2018