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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Oral Health

In brief

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.

Key facts

Study ID

NCT03693027

Run by

Primal Therapies Inc.

People needed

60

Starts

2018-06-01

Expected to finish

2018-12-31

Last updated by the study team

2018-10-09

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.

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).

Where it is running

• Benjamin Rose Institute on Aging — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.