Recruiting

Oral Care Lozenge

Sponsor:

Primal Therapies Inc.

Code:

NCT03693027

Conditions

Oral Health

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

PTx800 lozenges

Placebo control

Study Details

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

Study ID

NCT03693027

Start date

Jun 1, 2018

Status verified date

Oct, 2018

Completion date

Dec 31, 2018

Anticipated

Primary completion date

Dec 20, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

PTx800 lozenges

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

Placebo control

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Emily Stein, PhD

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

Farida Ejaz, PhD

216-373-16600fejaz@benrose.org

Locations

Benjamin Rose Institute on Aging

Recruiting

Cleveland, Ohio, United States, 44120

Contacts

Jenna Lovasz, BS

216-373-1771jlovasz@benrose.org

More Information

Sponsor

Primal Therapies Inc.

Last update posted

Oct 9, 2018

Last verified

Oct, 2018

Keywords

  • Older adults
  • microbiome
  • gum health
  • gingivitis
  • gum disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Primal Therapies Inc. on 2018-10-09.