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

NCT03693027 | Unknown

• 1 other identifier: 2017-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Health

Keywords

Older adults; microbiome; gum health; gingivitis; gum disease

Outcome Measures

Primary Outcomes (2)

• Change from Baseline of Bacterial Burden

  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

  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.

  Measured at baseline and at 6 weeks

Secondary Outcomes (1)

• Change from Baseline in oral health behaviors and habits

  Measured at baseline and at 6 weeks

Study Arms (2)

PTx800

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

PTx800 lozenges DIETARY_SUPPLEMENT

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

PTx800

Placebo control DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Primal Therapies Inc.: lead
• Benjamin Rose Institute on Aging: collaborator

Study Sites (1)

Benjamin Rose Institute on Aging

Cleveland, Ohio, 44120, United States

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Gingivitis; Gingival Diseases

Condition Hierarchy (Ancestors)

Infections; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Emily Stein

  Primal Therapies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Stein, PhD

CONTACT

510-847-8132; emily.stein@primaltx.com

Farida Ejaz, PhD

CONTACT

216-373-16600; fejaz@benrose.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 2, 2018
• Study Start: June 1, 2018
• Primary Completion: December 20, 2018
• Study Completion: December 31, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

US (1)