- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693027
Evaluation of a Daily Oral Care Lozenge on Oral Health and Quality of Life in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily Stein, PhD
- Phone Number: 510-847-8132
- Email: emily.stein@primaltx.com
Study Contact Backup
- Name: Farida Ejaz, PhD
- Phone Number: 216-373-16600
- Email: fejaz@benrose.org
Study Locations
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-
Ohio
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Cleveland, Ohio, United States, 44120
- Recruiting
- Benjamin Rose Institute on Aging
-
Contact:
- Jenna Lovasz, BS
- Phone Number: 216-373-1771
- Email: jlovasz@benrose.org
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
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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.
|
The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at baseline and at 6 weeks
|
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.
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.
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Measured at baseline and at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Measured at baseline and at 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily Stein, Primal Therapies
Publications and helpful links
General Publications
- LaMonte MJ, Genco RJ, Hovey KM, Wallace RB, Freudenheim JL, Michaud DS, Mai X, Tinker LF, Salazar CR, Andrews CA, Li W, Eaton CB, Martin LW, Wactawski-Wende J. History of Periodontitis Diagnosis and Edentulism as Predictors of Cardiovascular Disease, Stroke, and Mortality in Postmenopausal Women. J Am Heart Assoc. 2017 Mar 29;6(4):e004518. doi: 10.1161/JAHA.116.004518.
- Abbayya K, Puthanakar NY, Naduwinmani S, Chidambar YS. Association between Periodontitis and Alzheimer's Disease. N Am J Med Sci. 2015 Jun;7(6):241-6. doi: 10.4103/1947-2714.159325.
- Kaur S, White S, Bartold M. Periodontal Disease as a Risk Factor for Rheumatoid Arthritis: A Systematic Review. JBI Libr Syst Rev. 2012;10(42 Suppl):1-12. doi: 10.11124/jbisrir-2012-288.
- Kamer AR, Dasanayake AP, Craig RG, Glodzik-Sobanska L, Bry M, de Leon MJ. Alzheimer's disease and peripheral infections: the possible contribution from periodontal infections, model and hypothesis. J Alzheimers Dis. 2008 May;13(4):437-49. doi: 10.3233/jad-2008-13408.
- Maisonneuve P, Amar S, Lowenfels AB. Periodontal disease, edentulism, and pancreatic cancer: a meta-analysis. Ann Oncol. 2017 May 1;28(5):985-995. doi: 10.1093/annonc/mdx019.
- Momen-Heravi F, Babic A, Tworoger SS, Zhang L, Wu K, Smith-Warner SA, Ogino S, Chan AT, Meyerhardt J, Giovannucci E, Fuchs C, Cho E, Michaud DS, Stampfer MJ, Yu YH, Kim D, Zhang X. Periodontal disease, tooth loss and colorectal cancer risk: Results from the Nurses' Health Study. Int J Cancer. 2017 Feb 1;140(3):646-652. doi: 10.1002/ijc.30486. Epub 2016 Nov 23.
- Michaud DS, Joshipura K, Giovannucci E, Fuchs CS. A prospective study of periodontal disease and pancreatic cancer in US male health professionals. J Natl Cancer Inst. 2007 Jan 17;99(2):171-5. doi: 10.1093/jnci/djk021.
- Fardini Y, Wang X, Temoin S, Nithianantham S, Lee D, Shoham M, Han YW. Fusobacterium nucleatum adhesin FadA binds vascular endothelial cadherin and alters endothelial integrity. Mol Microbiol. 2011 Dec;82(6):1468-80. doi: 10.1111/j.1365-2958.2011.07905.x. Epub 2011 Nov 15.
- Lamster IB. Oral health care services for older adults: a looming crisis. Am J Public Health. 2004 May;94(5):699-702. doi: 10.2105/ajph.94.5.699. No abstract available.
- McClearn GE, Svartengren M, Pedersen NL, Heller DA, Plomin R. Genetic and environmental influences on pulmonary function in aging Swedish twins. J Gerontol. 1994 Nov;49(6):264-8. doi: 10.1093/geronj/49.6.m264.
- Lee KH, Wu B, Plassman BL. Cognitive function and oral health-related quality of life in older adults. J Am Geriatr Soc. 2013 Sep;61(9):1602-7. doi: 10.1111/jgs.12402. Epub 2013 Aug 26.
- Park H, Suk SH, Cheong JS, Lee HS, Chang H, Do SY, Kang JS. Tooth loss may predict poor cognitive function in community-dwelling adults without dementia or stroke: the PRESENT project. J Korean Med Sci. 2013 Oct;28(10):1518-21. doi: 10.3346/jkms.2013.28.10.1518. Epub 2013 Sep 25.
- Del Brutto OH, Gardener H, Del Brutto VJ, Maestre GE, Zambrano M, Montenegro JE, Wright CB. Edentulism associates with worse cognitive performance in community-dwelling elders in rural Ecuador: results of the Atahualpa project. J Community Health. 2014 Dec;39(6):1097-100. doi: 10.1007/s10900-014-9857-3.
- Lee KH, Plassman BL, Pan W, Wu B. Mediation Effect of Oral Hygiene on the Relationship Between Cognitive Function and Oral Health in Older Adults. J Gerontol Nurs. 2016 May 1;42(5):30-7. doi: 10.3928/00989134-20151218-03. Epub 2015 Dec 29.
- Joshy G, Arora M, Korda RJ, Chalmers J, Banks E. Is poor oral health a risk marker for incident cardiovascular disease hospitalisation and all-cause mortality? Findings from 172 630 participants from the prospective 45 and Up Study. BMJ Open. 2016 Aug 30;6(8):e012386. doi: 10.1136/bmjopen-2016-012386.
- Ruokonen H, Nylund K, Furuholm J, Meurman JH, Sorsa T, Kotaniemi K, Ortiz F, Heikkinen AM. Oral Health and Mortality in Patients With Chronic Kidney Disease. J Periodontol. 2017 Jan;88(1):26-33. doi: 10.1902/jop.2016.160215. Epub 2016 Aug 13.
- Beukers NG, van der Heijden GJ, van Wijk AJ, Loos BG. Periodontitis is an independent risk indicator for atherosclerotic cardiovascular diseases among 60 174 participants in a large dental school in the Netherlands. J Epidemiol Community Health. 2017 Jan;71(1):37-42. doi: 10.1136/jech-2015-206745. Epub 2016 Aug 8.
- Friedman PK, Lamster IB. Tooth loss as a predictor of shortened longevity: exploring the hypothesis. Periodontol 2000. 2016 Oct;72(1):142-52. doi: 10.1111/prd.12128.
- Padilha DM, Hilgert JB, Hugo FN, Bos AJ, Ferrucci L. Number of teeth and mortality risk in the Baltimore Longitudinal Study of Aging. J Gerontol A Biol Sci Med Sci. 2008 Jul;63(7):739-44. doi: 10.1093/gerona/63.7.739.
- American Dental Association Health Policy Institute. HPI: unmet dental needs falling for children, rising for low-income adults, seniors. ADA News. Sept 27, 2016.
- US Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General- Executive Summary. Rockville, MD: US Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health, 2000.
- CDC report 2004: https://www.cdc.gov/aging/pdf/ state_of_aging_and_health_in_america_2004.pdf
- Shay K. Infectious complications of dental and periodontal diseases in the elderly population. Clin Infect Dis. 2002 May 1;34(9):1215-23. doi: 10.1086/339865. Epub 2002 Apr 2.
- Persson RE, Persson GR. The elderly at risk for periodontitis and systemic diseases. Dent Clin North Am. 2005 Apr;49(2):279-92. doi: 10.1016/j.cden.2004.10.006.
- Komiya K, Rubin BK, Kadota JI, Mukae H, Akaba T, Moro H, Aoki N, Tsukada H, Noguchi S, Shime N, Takahashi O, Kohno S. Prognostic implications of aspiration pneumonia in patients with community acquired pneumonia: A systematic review with meta-analysis. Sci Rep. 2016 Dec 7;6:38097. doi: 10.1038/srep38097.
- Marsh PD, Zaura E. Dental biofilm: ecological interactions in health and disease. J Clin Periodontol. 2017 Mar;44 Suppl 18:S12-S22. doi: 10.1111/jcpe.12679.
- Gross EL, Beall CJ, Kutsch SR, Firestone ND, Leys EJ, Griffen AL. Beyond Streptococcus mutans: dental caries onset linked to multiple species by 16S rRNA community analysis. PLoS One. 2012;7(10):e47722. doi: 10.1371/journal.pone.0047722. Epub 2012 Oct 16.
- Peterson SN, Snesrud E, Liu J, Ong AC, Kilian M, Schork NJ, Bretz W. The dental plaque microbiome in health and disease. PLoS One. 2013;8(3):e58487. doi: 10.1371/journal.pone.0058487. Epub 2013 Mar 8.
- Hajishengallis G, Liang S, Payne MA, Hashim A, Jotwani R, Eskan MA, McIntosh ML, Alsam A, Kirkwood KL, Lambris JD, Darveau RP, Curtis MA. Low-abundance biofilm species orchestrates inflammatory periodontal disease through the commensal microbiota and complement. Cell Host Microbe. 2011 Nov 17;10(5):497-506. doi: 10.1016/j.chom.2011.10.006. Epub 2011 Oct 27.
- Hajishengallis G, Lamont RJ. Beyond the red complex and into more complexity: the polymicrobial synergy and dysbiosis (PSD) model of periodontal disease etiology. Mol Oral Microbiol. 2012 Dec;27(6):409-19. doi: 10.1111/j.2041-1014.2012.00663.x. Epub 2012 Sep 3.
- CDC report 2008 https://www2c.cdc.gov/podcasts/media/pdf/ HealthyAging_OralHealth.pdf
- Fox PC and Eversole LR. Diseases of the salivary glands. In: Silverman S, Eversole LR, Truelove EL, eds. Essentials of Oral Medicine. Ontario, Canada: BC Decker; 2002:260-276
- From Medicare website: (https://www.medicare.gov/coverage/dentalservices. html).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2017-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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