Next Science Antimicrobial Mouth Rinse Study
Completed · Phase 1 · Has a placebo group
Conditions studied: Gingivitis, Dental Plaque
In brief
To assess the effect of a test antimicrobial oral rinse from Next Science on the prevention of oral biofilm formation and thereby preventing gingivitis by monitoring the oral microbial flora and measuring gingival inflammation and bleeding.
Key facts
- Study ID
- NCT03154021
- Run by
- University of Florida
- People needed
- 118
- Starts
- 2017-08-28
- Expected to finish
- 2018-05-15
- Last updated by the study team
- 2019-02-18
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Be between the ages of 18 and 60
- Provide written informed consent prior to participation and be given a signed copy of the informed consent form (ICF).
- Be in good general health as determined by the investigator/designee based on a review of the Medical history/update for participation in the study;
- Have at least 20 gradable teeth;
- Have 10 or more bleeding sites at Baseline
You may not qualify if…
- Known allergies or sensitivity to oral rinse products, especially those containing cetylpyridinium chloride (CPC), sodium hydroxide or potassium dihydrogen phosphate.
- Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession.
- Active treatment for periodontitis.
- Braces
- Diabetes
- Antibiotic use within three months of the Baseline, Visit 1.
- Pregnancy
- Any diseases or conditions that could be expected to interfere with the subject safely completing the study.
- Continuance Criteria
- Subjects may be excluded from the study or the analysis due to:
- Use of antibiotics any time during the study;
- Use of any non-study oral hygiene products during the study;
- A non-study dental prophylaxis or other elective dentistry during the study
Where it is running
- Dental Clinical Research Unit, University of Florida — Gainesville, Florida, United States
- University of Florida College of Dentistry — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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